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17 days old

Manufacturing Validation Engineer

Kelly Services
St Louis, MO 63112
Kelly Services is currently looking to hire a **Manufacturing Validation Engineer** to work for one of our top Medical Device clients on-site in St. Louis, MO for a long-term contract position.


**Primary activities will include:**


+ Actively participate in cross-functional MDR Team R+D, QA, Manufacturing, Manufacturing Engineering initiatives to identify and close gaps in the Disposable Equipment/Process Validations, including but not limited to: Multi-vac Form-Fill-Seal Equipment, HiPS Tray Sealer Equipment, PETG Tray Sealer Equipment, Auto-pouch Sealer Equipment

+ Perform detailed evaluations of existing/cumulative IQ/OQ/PQ documentation to identify potential gaps to the MDR requirements and/or demonstrate traceability for MDR compliance

+ Draft and obtain cross-functional approval of Engineering Rationale/ justification to close qualification gaps where it is deemed physical testing is not required to demonstrate MDR compliance

+ Draft Packs equipment validation protocols IQ, OQ, and PQs where it is deemed physical testing is required to demonstrate MDR compliance

+ Execute process validations and generate validation reports in instances where protocol failures occur., work with cross-functional team to identify Root Cause of failure, implement CA and revalidate as required

+ Mitigation of other Packs process and documentation issues/updates to address MDR requirements e.g. updates to SOPs, PFMEAs, process qualifications, etc.

+ Design, evaluation, and qualification of production tooling.

+ Perform component level root-cause analysis and resolution to ensure production continuity.

+ Assist in generating CAD documentation, authorizing SOP s and test instructions, and creating/updating PFMEAs in accordance with Quality Systems Regulations.

+ Resolve manufacturing issues to minimize production downtime.

+ Proactively participate on new product and process design teams, as well as perform change coordination that may impact assembly operations and test processes


**Qualifications:**


+ Bachelor degree in engineering or other technical field required

+ Knowledge of the medical device industry is preferred

+ Knowledge of Quality Systems standards and regulations and Quality Assurance.

+ Knowledge of Lean Manufacturing Concepts

+ Knowledge of problem solving through the DMAIC process.

+ Minimum of 4 years of experience in an equivalent or related role

+ Ability to read and interpret engineering drawings, specs, method sheets, or other engineering / manufacturing documentation.

+ Strong knowledge of mechanical systems

+ Basic working knowledge of electrical systems

+ Ability to perform word processing presentation slides, project schedules. ability to analyze data with spreadsheets or similar software.

+ Experience with SolidWorks or other computer modeling software.


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.


**Why Kelly?**


+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-10-04 Expires: 2021-11-04

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Manufacturing Validation Engineer

Kelly Services
St Louis, MO 63112

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