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Manufacturing Jobs in New+Paris, OH within the last 30 days

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Location Title Company Pay Date

US
OH
Cincinnati

Production Supervisor – Bulk Manufacturing

Amylin Pharmaceuticals   7/29
Details: Location: Cincinnati, OH Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and were always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge. Responsibilities Line clearances, cleaning/sanitization, CIP and SIP process equipment, filter testing, operation of microsphere process equipment Assists with the operation and maintenance of production equipment. Ensures weights, measures and raw materials are managed appropriately to assure batches manufactured contain proper ingredients and quantities. Execute validation protocols for processes and equipment. Maintain records and a clean environment to comply with regulatory requirements. Read, Understand, and comply with Good Manufacturing Practices and Standard Operating Procedures. Assist associates with in-process testing to assure batches meet specifications. Review/update current SOPs/batch records as well as write new SOPs/ batch records, and protocols. Supervise production activities including Formulation and Sanitization. Lead troubleshooting and process improvement activities including corresponding documentation activities. Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance. Initiate appropriate action when process deviations occur. Supervise day to day activities of production associates. Perform OJT for new and developing operators. Manage the performance of Production Associates and Leads, including merit reviews, professional development and disciplinary action. Schedule production activities and coordinate activities of support groups. Openly communicate production priorities and progress to team on a continuing basis.

US
OH
Cincinnati

Sr. Aerospace Composite Manufacturing Engineer

CTL Aerospace, Inc.   7/29
Details: CTL Aerospace is a full service; NADCAP certified composite-manufacturing company providing services to the major aerospace and governmental affiliates since 1946. CTL specializes in the manufacturing of Fiber Reinforced Polymer Structures.We are seeking talented professionals due to our increased sales volume to work in a fast-paced, team oriented environment as a Aerospace  Manufacturing Engineer at our northern Cincinnati, Ohio location (less than 30 minutes from Dayton and/or Northern Kentucky).CTL is stable, successful, and growing. This position offers an excellent opportunity for an Aerospace  Manufacturing Engineer with career goals to work in an empowered setting with a broad scope of authority.

US
OH
Dayton

B2B Sales / Industrial, Manufacturing

ASN B2B $48,000 - $80,000/Year 7/29
Details: Business to Business Sales Rep / B2B Sales Rep / Outside Sales Rep / Account Executives We are currently seeking aggressive individuals with excellent communication skills to call on local and national firms based in the local area. If you are tenacious with a strong desire to succeed we would love to discuss our opportunites with you.   ***TO BE CONSIDERED FOR THESE POSITIONS, YOU MUST CALL TO SPEAK WITH A REPRESENTATIVE:  1(866)-929-0091 / Job ID #30*** As an Outside Sales Representative, you will be responsible for managing a given territory. Working with a defined sales quota, you will focus on selling value and innovative solutions to decision-makers within companies. You must be results oriented, self motivated and driven by both financial and career opportunities. There are extremely competitive compensation plans available.  Base Salaries are ranging anywhere from $48,000 to $80,000 per year with benefits.  Average bonus and commission adds an additional $10,000 to $20,000 per year. If you are interested in being an account executive, sales representative, account manager or have had an interest in sales please call today and speak with a representative.   PLEASE CALL 1(866)929-0091 / Job ID #30 TO SPEAK WITH ONE OF OUR REPRESENTATIVES TODAY.

US
OH
Southwest Ohio

Manufacturing Engineer – Advanced Products Launch

The Albrecht Group   7/29
Details: Manufacturing Engineer – Advanced Products Launch Our client, a well-established and growing custom manufacturer that supplies high volume metal parts and assembled components to a diversified customer base, is seeking a Manufacturing Engineer/Manufacturing Launch Leader to manage the launch of their Advanced Products in its multi-site manufacturing organization; this position will be based in Southwest Ohio. The company is ISO 9001 qualified and participates in a variety of “green" and energy conservation initiatives. The Manufacturing Engineer/Launch Leader will play key “cradle to launch" role in the launch of new programs and advanced products and guide the engineering and manufacturing organization through forward planning to establish cost effective designs and processes for new products.  Candidates must have significant metal stamping and machining experience and a track record of guiding projects to successful conclusion.  This is a career opportunity with significant promotion and advancement opportunities. The company has a number of new advanced products moving through the development process with launch timeframes at their various locations in the near future.  Additionally, the company’s long-term strategy will continue to focus on new product development and will rely heavily on the expertise of the Manufacturing Engineer to bring these products from “concept to the customer" and drive corporate success well into the future. Additional responsibilities and accountabilities for the Manufacturing Engineer include Prepare multi-functional detailed launch plans Lead cross-functional teams including customer staff to define launch requirements Coordinate closely with the manufacturing and engineering staffs on forward planning for advanced products Provide guidance on the selection of new equipment Review supplier proposals concerning outside manufacturing, services and equipment additions Provide expert input to the cost analysis staff Provide leadership in troubleshooting new processes and procedures.

US
OH
Cincinnati

Director of Manufacturing Operations

RLStevens & Associates   7/25
Details: DIRECTOR of MANUFACTURING OPERATIONS  http://www.executivejoboffers.com/ If you are looking to regain a work / life balance and need a new stimulating challenge, but think your options are limited due to your time-crunched schedule we can:    Streamline your search Increase your effectiveness by providing focus and direction Maximize your exposure to the right opportunities, companies, and decision makers  For 28 years, RLStevens has helped business leaders leverage their portfolio of problem-solving, team-building and business-growth talents to make a successful career change in industry and / or functionality. Our career marketing services have been valuable for executives, vice presidents, chief administrative officers, operations managers, project managers, directors, and other business leaders. We do charge a fee for our professional and executive services. Services are based upon the needs of the client which are determined after a careful evaluation is completed.  The evaluation establishes the exact work to be done for you in accordance with your career goals. We guarantee to work with our clients until they have accepted a position of their choice. Fees range 4%–10%.  Depending upon marketability ( we customize ) the final payment, in many cases, is due within 30 days of accepting a new position.  Fees are not recurring.     Contact us now:http://www.executivejoboffers.com/cincinnati   Submit your resume to:   800-215-3616 toll free       Key Words: President, CEO, COO, CMO, CFO, EVP, operations, strategic planning, organizational development, Return-on-Investment, business development, process improvement, human resource, RLStevens, RL Stevnens, R.L. Stevens

US
KY
Florence

Manufacturing Positions

Staffmark $12.00 - $15.50/Hour 7/23
Details: A global plastics manufacturer in Florence, KY currently has manufacturing positions available.  Responsibilities include: Handle raw materials and finished product with sit down forklift Clean machinery and equipment used in manufacturing package product in bags and boxes Feed raw materials into extruders The manufacturing department is a 24/7 operation.  Day shift is 4:55 AM to 5:10 PM, night shift is 4:55 PM to 5:10 AM.  Crews are scheduled for 3 and 4 day weeks, and they rotate shifts every two months.  Overtime shifts available.

US
IN
Anderson

Manufacturing Engineering Manager

Mancor Industries   7/23
Details: Manufacturing Engineering ManagerMancor Industries, a world-class precision manufacturer of metal components and sub-assemblies, is searching for an experienced, hands-on, motivated, and self-directed manufacturing engineering manager for its Anderson, Indiana, location.  Mancor’s vision is to be the recognized “first-in-class" supplier in the industry. In other words, Mancor simply wants to be the best in terms of quality, delivery, and value. The manufacturing engineering manager utilizes lean manufacturing, Six Sigma, and SPC to develop and improve manufacturing processes for fabricating components for the heavy equipment and transportation industry. The position coordinates activities with manufacturing, quality, sales, maintenance, and others with the objective of improving processes and quality while minimizing costs.Key Responsibilities Contribute to key strategic planning and decision making regarding new technologies, processing, and machining and tooling capabilities. Plan and establish engineering schedules; standardize existing operation procedures and instructions; lead new process development. Oversee various manufacturing process/engineering projects; manage costs, timing, design, bidding, and implementation: identify and implement cost-reduction opportunities through process redesign and improvement. Establish new guidelines, best practices, and routines based on engineering standards to assure operational capabilities, quality, safety, lead-time reductions, and cost effectiveness as necessary; serve as a strategic source to lead continuous improvement. Follow up on performance and measure it against initial estimates; implement SPC to control process variation; review cost control and statistical data; participate in cost-reduction projects. Identify manufacturing process problems, troubleshoot causes, and develop/implement solutions; ensure completion in a timely manner to prevent lost production time; recommend new policies or procedures as necessary. Ensure equipment and systems adhere to safety requirements, as well as local, state, and federal industry regulations.

US
OH
Cincinnati

Manufacturing Sales Representative

HydraTech Engineered Products   7/23
Details: Our company is a manufacturer of coatings and a fabricator of unique pipeline repair products for the trenchless technology business. Product lines range from experienced products to recently engineered viable products that are formulated and designed at our facility. Product lines are sold domestically and internationally to end users, contractors and distributors. Position is available IMMEDIATELY for a sales representative with the ability to learn from our senior sales representative. This candidate should be organized, able to work in an office environment and have the ability to understand technical products. In addition, the candidate shall support and provide sales through the use of  ACT!, work wih marketing and sales personnel as well as working independently calling and communicating with potential customers. Some travel is required to work at tradeshows and for face to face meeting with clients.

US
OH
Coldwater

Manufacturing Engineer

Adecco Technical   7/22
Details: Adecco Technical is the leading provider of contract personnel and related staffing services. As a division of Adecco, Adecco Technical has more than 135 offices in the U.S. alone. With more than 40 years of experience in the technical staffing industry we've got the people, experience, and technology to deliver the right people. Adecco Engineering & Technical is currently recruiting for a Maufacturing Engineer for one of its clients in Coldwater, OH. DURATION: Permanent SALARY/HOURLY RATE: TBD JOB DESCRIPTION: The Manufacturing Engineer evaluates and recommends manufacturing processes and equipment to apply to new and existing products. The Manufacturing Engineer keeps up to date with the latest manufacturing techniques to assure efficient production. REQUIRED SKILLS: BS degree in Mechanical or Industrial EngineeringSheet metal work including slear, shear, brake and punch presses Roll-forming CNC fabrication equipment including turrets, mills and lathes Tool and die design Quick die change methodologies Laser and plasma cutting Welding and finishing General machine mechanics Work cell design and time studies Calculation of ROI Assembly technologies for low, medium and high volume applications For immediate consideration, please forward resumes with salary requirement to: Resumes should be in traditional format, meaning that for each job listed, include company name, city/state, dates worked there, job title, and job responsibility.Adecco Technical is an Equal Opportunity Employer (EOE).

US
KY
Florence

MANUFACTURING QUALITY TECHNICIAN

Beckman Coulter   7/22
Details: Job Title : MANUFACTURING QUALITY TECHNICIANRequisition Number : 78510Location : Florence , KY ,41042 Performs all aspects of instrument or product line assessment testing by simulating end use customer operation following detailed test procedures. Uses a variety of procedures, test equipment and/or test fixtures to qualify, assign and accept or reject an instrument or production line. Documents test results and verifies compliance to specification. May complete re-work on assemblies and/ or systems as a result of testing. Assist in the in-process testing of hematology reagents. Responsibilities include: Laboratory testing on in-process samples for pH and  other parameters to ensure adherence to specification. Conduct weight and volume checks as well as lot number and expiration date verification on in-processsamples. Calibrate and maintain in-process instrumentation. Issue and perform label verification for product labeling. Verify line status prior to manufacturing. Assist in the adjustment of production batches.

US
OH
Dayton

Manufacturing Supervisor 2999

MRC Staffing Solutions   7/20
Details: Reports to: Plant Manager

US
OH
Dayton

Manufacturing / Industrial

Anchor Personnel Services $8.50 - $11.00/Hour 7/16
Details: Anchor Personnel Services, Inc has partnered with several Manufacturing/Industrial companies in the Greene, Montgomery, and Warren county area.  Openings are available on 1st, 2nd, and 3rd shift. Most positions require OT and some weekend work.  Positions are Full Time.  We have the following openings:General Manufacturing Forklift/Crane work Champfuring Basic machine operation Loading and unloading when required Some heavy lifting Fast paced environment Excellent timeliness and attendance a must General Resurfacing Tech Processing and sorting parts Basic machine operation Some heavy lifting Part inspection Packaging of materials for shipments Plastic Injection Molding Run basic machines Exceptional attention to detail Package parts Work as a member of a line or individually High volume

US
KY
Taylor Mill

Manufacturing Engineer Manager

Progress Rail Services   7/16
Details: Progress Rail Services, a division of Caterpillar and a leading supplier in the railroad industry, currently has an opening for a Manufacturing Engineer Manager who will coordinate and lead activities concerned with the manufacturing engineering, machine tool selection and setup, tooling and CNC programming at our plant located in Northern KY. The successful candidate will be results-oriented, demonstrate team leadership, and understand team dynamics. He/She will manage the manufacturing engineering team and perform engineering tasks including planning, value engineering, root cause and corrective action investigations, new product release, continuous improvement teams, training, application of manufacturing processes, and the ability to accomplish tasks through influencing others. The Manufacuring Engineer manager will: Provide technical leadership, mentoring, and supervision of manufacturing & test engineering personnel. Interface with operations to ensure compliance to all manufacturing processes. Analyze root causes of deficiencies and ensure proper corrective actions are implemented in a timely manner. Lead cross-functional team efforts to improve products and processes. Lead new product launches, create and design technical programs to ensure manufacturing processes are meeting customer and quality satisfaction. Review practices, procedures and processes seeking avenues to improve efficiency and effectiveness and reduce risk to product quality. Design and implement new fixtures to reduce setup time and improve process repeatability. Implement latest cutting tool technology to improve quality and efficiency. Establish process controls and mistake-proofing/error reduction of products and processes.

US
IN
Greater Cincinnati

Senior Manufacturing Engineer

Aurora Casket Company   7/15
Details: Discover a world of opportunities with Aurora Casket Company.  A family owned business established in 1890, Aurora is the largest privately owned casket manufacturer in the country. Under the leadership of the Backman and Barrott families, with more than 900 employees, Aurora has grown into a successful and innovative international company with more than 60 service centers nationwide.  Aurora is currently searching for an experienced Senior Level Manufacturing Engineer.  A leading technology innovator, Engineers at Aurora have a significant impact on new product development, manufacturing automation and process improvement.   Located just minutes from Cincinnati, it’s more than just a Greater Cincinnati Company with opportunities to travel and work in its other manufacturing plants, including our locations outside the US.The successful candidate will perform a variety of manufacturing engineering work using lean manufacturing principles implementing new equipment and processes.  We require 15+ years experience in the manufacturing engineering field with experience in the following areas:  equipment design and implementation, equipment layout, capital expenditure and ROI analysis, automation, robotics, large press and dies and proven project skills.  Solid Edge, Maynard (Most) time study methodology, PLC experience a plus.

US
OH
Cincinnati

Manufacturing Techs, Buyer, Planner, Quality Control Chemists

Patheon Pharmaceuticals, Inc.   7/14
Details: A relationship you can count on, from pharmaceutical development to commercial manufacturing. Service - it’s what Patheon Pharmaceuticals Inc. is all about. Providing the best commercial manufacturing and drug development services to the pharmaceutical and biotechnology industries is our mandate. MANUFACTURING TECHNICIANS (Ref #P-0646-A)  for all Production shifts. Candidates should have prior Pharmaceutical experience in Coating, Compressing/Encapsulation and/or Granulation. Duties and Responsibilities include: Prepare manufacturing areas & equipment for the production of pharmaceutical products, manufacture products in accordance with batch records & clean processing equipment & rooms in accordance with written Standard Operating Procedures (SOPs) & established Good Manufacturing Practices (cGMPS). Must also effectively troubleshoot equipment & ensure that product quality meets the standards of Patheon, our clients, and applicable regulatory agencies at all times. Requirements: In addition to prior Pharmaceutical experience, applicants must have strong math & reading skills, good documentation skills, strong mechanical aptitude, & the ability to lift up to 75 lbs frequently throughout a shift. Desired Education: High School Diploma or Equivalent. BUYER – INVENTORY PURCHASING (Ref #P-0645) --   Duties & Responsibilities include: Evaluates the marketplace for raw & packaging materials & selects suppliers that can meet the business needs. Develops knowledge of supplier’s processes, capabilities, & capacities. Uses research & analysis to develop & select alternative sources & materials. Commits Company on routine & moderately complex agreements. Participates on North American & Global spend teams to evaluate commodities & buying potential. Instrumental in seeking out cost savings initiatives. Expedites orders from origination through delivery & supplier payment. Builds relationships with suppliers & handles invoice discrepancies & quality issues. Supports development & launch of new products. Uses SAP purchasing system, RFQ/RFI, spreadsheet applications, & communications as tools to achieve results.  Requirements: Minimum 5 years purchasing experience preferred. CPM or equivalent desired. SAP systems & Excel knowledge preferred. Experienced in the acquisition of highly strategic or unique materials & services while optimizing total cost of ownership. Proficient in negotiating skills, problem solving, purchasing policy & procedures, business conduct & business law. Possess excellent communications, interpersonal & problem solving skills. Desired Education: Business degree or equivalent business experience required. PLANNER (Ref #P-0606) --  Duties and Responsibilities include: Plans, coordinates & controls assigned finished goods & semifinished goods product, raw & package materials, & workflow to achieve high Client Service levels, lowest inventory investment, & highest plant efficiency. Uses SAP planning system, Taylor Shop Floor scheduling system, spreadsheet applications, make-to-order planning techniques/knowledge, & professional direct to client communications to achieve results. This position is responsible for developing production plan/schedules for Manufacturing & Packaging areas; coordinating material requirements with Purchasing Dept; & coordinating product Purchase Orders with Clients. Acts as Planning Dept. focal point for transferring products from Development Services to Commercial & for product launch activities. Initiates & maintains SAP data accuracy for assigned materials, along with SOR data. Works with cross-functional areas of the site as well as the Client to achieve expected results. Requirements: APICS certification preferred. At least 2 years Production Planning, Scheduling & Inventory Management experience required. Pharmaceutical or related business preferred. Strong SAP system knowledge required. Strong spreadsheet experience with emphasis on planning/coordination/accounting techniques. Must be customer focused, have abilities to resolve conflict, good communication skills, is action oriented & a team player. Desired Education: Bachelor of Science, Business, Materials Management, Supply Chain or related field. QUALITY CONTROL CHEMISTS (Ref #P-0591)/ANALYTICAL DEVELOPMENT CHEMISTS (Ref #P-0650) --    Duties and Responsibilities include: Performs wet chemical, chromatographic (HPLC and GC) and other tests specific to the industry utilizing the latest instrumentation. Must have strong problem-solving skills. Prior pharmaceutical analysis or cGMP experience desired. Desired Education: BS or BA in Chemistry with 0-10 years relevant experience. PROCESS PHARMACISTS (Ref #P-0594) -- Duties and Responsibilities include: This is a multi-functional position supporting pharmaceutical manufacturing operations in the Production Manufacturing Unit. Broad-based background in pharmaceutical manufacturing with a combination of experience & skills in one or more of the following areas: product/process development, production support, engineering, validation or quality assurance. Strong written & verbal communication; project management skills are essential as the position requires interaction & collaboration with the Patheon Development Services organization, outside clients, other supervisory/technical staff & shop floor associates. Position focuses on leading new product opportunities including transition between development and operations, scale-up, validation & commercial launch activities while maintaining a high level of focus on process safety & product quality. Responsibilities include investigating & implementing improvements to existing manufacturing processes concentrating in areas of equipment & processing, trouble shooting of processing difficulties, supporting equipment qualification, introducing new technologies to the manufacturing area, cleaning validation & supporting Patheon Continuous Improvement Teams. The successful candidate must be flexible with respect to diversified assignments.  Requirements: A minimum of 3 - 5 years of experience in the pharmaceutical manufacturing environment is desired. Broad knowledge of pharmaceutical manufacturing processes, pharmaceutical development and engineering principles is required. A thorough knowledge of cGMPs, SOPs, regulatory compliance, equipment qualification and process validation protocols is also a requirement. Periodic travel may be required to support projects.Desired Education: BS degree in pharmacy, engineering or other related technical discipline is required. MANUFACTURING MECHANIC (Ref #P-0578A) --  Duties and Responsibilities include: Perform preventative maintenance on, troubleshoots, & repairs manufacturing equipment. This includes, but is not limited to mechanical, pneumatic, hydraulic and 240 - 480V controls as well as APACs/Rockwell Automation controlled granulation equipment, tablet presses & coating pans. Responds promptly to shifting priorities. Performs preventive maintenance per schedule & as needed. Assists manufacturing operators in set-ups & set-up simplification. Performs necessary adjustments, repairs, set-ups and/or maintenance during production to improve quality, safety & overall department efficiency. Maintains equipment files. Orders spare parts & maintains inventory records when needed. Assists manufacturing operators, engineers & supervisors with equipment installations, modifications, improvements & safety related projects. Requirements: 1+ year pharmaceutical experience. Mechanical aptitude. Familiar with Microsoft Office applications. Ability to read / understand piping & instrument diagrams, schematics, wiring diagrams & other specialized documentation. Department experience, knowledge of APACs and Rockwell Automation & NFPA 70E awareness are desirable. Job will require wearing of NFPA 70E personal protective equipment as well as Tyvek® coveralls and various styles of respirators. Interpersonal skills to allow successful work in a team environment & communication skills are necessary. Desired Education: High School Diploma or Equivalent. Qualified candidates are invited to send resumes, referencing the position and job code, to: Patheon Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, OH 45237;  email (preferred):   CRO_R .   We appreciate your interest; however, only candidates selected for an interview will be contacted. EEO/M/F/D/V

US
IN
Liberty

Assistant Manufacturing Accounting Manager

NSK Corporation - LIberty   7/14
Details: This position will provide the plant with a central point of supervision for the operation of the Accounting and Cost Control activities and to provide a central source for such related information and records.  Major responsibilities are to: Supervise, assist and provide guidance and direction to accounting clerks in their various department responsibilities.  Secondary, supplies training and evaluates their performance. Prepare indicators each month to evaluate and measure the efficiency of plant performance. Reconciles perpetual inventories monthly and investigates existing problems; do cycle counts and observe existing controls.  Assists in organizing physical inventory. Analyze each months performance against Business Plan and supplies information for cause of variance. Prepares forecast each month, utilizes appropriate resources for any variances that may occurs to Business Plan. Closes financial books at month end complying with all government statutes, rules and regulations.  Assists in preparation of annual budget to keep cost under control; prepares miscellaneous reports to present financial information to service different needs; responsible for the development and administration of department goals, objectives and action plans. Leads and/or participates in small group activities for the purpose of plant growth.

US
OH
Dayton

MANUFACTURING WELDING ENGINEER

Henny Penny   7/9
Details: We are looking for a multi – talented Engineer to join our Manufacturing team. The individual in this position will play a key role planning and designing our welding processes. This person will work closely with both Production and Design Engineering Groups by providing sheet metal assembly and fabrication knowledge for new product introductions and design issues.    In this role, you would be based at our world headquarters in Eaton, Ohio.  Key responsibilities would include: ·         Lead process development efforts to optimize sheet metal welding methods·         Determine parts and tools needed in order to achieve manufacturing goals according to product specifications·         Lead cross functional teams for corporate problems solving initiatives ·         Provide technical support for production and design groups

US
OH
Cincinnati

Manufacturing Control Systems Validation Engineer

E-Technologies Group   7/6
Details: E-Technologies Group is a project-based engineering firm specializing in automation, design, business intelligence, information technology, and validation.  We have been providing high-value engineering solutions and services for all phases of project execution since 1993. Our commitment to our clients has earned us a high degree of customer loyalty and our highly qualified and experienced staff is the foundation of our business.E Technologies Group headquarters is located approximately 15 miles north of Cincinnati and 35 miles south of Dayton in West Chester, Ohio.  Our modern facilities include a training center and a fully equipped lab and staging area.  E-Tech strives to be the best company to work for, offering competitive pay and benefits package.   Our recent achievements include being named a Top 100 consulting firm by Inc. magazine and one of Greater Cincinnati’s “Fast 55" companies, a ranking of the region’s fastest-growing companies.

US
OH
Sidney

Regulatory Manager - Medical Device Manufacturing

  7/28
Details: Please Note: If you would like to be considered for this position then please email your resume as a Microsoft Word Document AttachmentREGULATORY MANAGER (Medical Device Manufacturing)Northwest OhioSummary:  This position assures company compliance to all pertinent United States F.D.A., state, and international regulatory requirements which are applicable to the design, manufacture and distribution of medical and diagnostic devices by performing the following duties: Essential Duties and Responsibilities include the following. Other duties may be assigned.   Develops content and format for regulatory submissions. Coordinates submission of annual FDA registration, updates to device listing, MDR’s, 510(k)’s, and recall notices. Coordinates submission of documentation for international regulatory requirements including the European Medical Device Directive (CE marking) and other countries as business needs dictate. Advises corporate personnel regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments. Negotiates directly with regulatory authorities regarding company's filings. Develops, implements, and reviews current policies and practices affected by updates issued by Federal and international regulatory agencies. Coordinates with other departments, corporate or marketing partners, and international offices to achieve project goals. Conducts Incident investigations, risk analysis, and post market surveillance. Coordinates responses to external requests for product regulatory information, test reports, and certificates.Coordinates insurance, legal, and product liability issues with legal counsel.Assists in performing internal quality system, supplier, notified body and FDA QSIT audits.Reviews regulatory publications to keep apprised of new regulatory developments. Competency:To perform the job successfully, an individual should demonstrate the following competencies   Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others. Interpersonal - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things. Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results .Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Inspires respect and trust; Accepts feedback from others; Provides vision and inspiration to peers and subordinates; Gives appropriate recognition to others; Displays passion and optimism; Mobilizes others to fulfill the vision. Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness. Visionary Leadership - Displays passion and optimism; Inspires respect and trust; Mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates. Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals. Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue ; Conserves organizational resources. Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity. Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions. Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed. Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention. Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans. Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions ; Uses equipment and materials properly.                                        Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education/Experience:Bachelor's degree (B. A.) from four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.

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