Akkodis is seeking an Onsite Sr. Medical Device Quality/ Validation Engineer for a 12 to 24 month contract position with a client located in Billerica, MA. You will develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. You will support cardiac catheter manufacturing.

Pay/Salary Range: $55.00 to $65.00 per hour depending on experience.

Sr. Medical Device Quality/ Validation Engineer job responsibilities include:

• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality

QUALIFICATIONS:

• Mechanical Engineering background – BSME

• Must have five years of expertise in Process Validation, Computer Software Validation (CSV), Process Characterization / Validation – IQ,OQ,PQ, Test method Validation (TMV) and Equipment Qualification. Experience using data/KPI’s/Metrics, and other tools and systems like MOS, CAP & Lean Six Sigma. Experience working with Disposable Medical Devices / Capital Equipment is ideal.

• Understanding of Risk ISO 14971, Quality systems ISO 13485

• Manufacturing Process Improvements

• Medical Device Manufacturing

• PFMEA updating

If you are interested in this Onsite Sr. Medical Device Quality/ Validation Engineer job in Billerica, MA then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

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The Company will consider qualified applicants with arrest and conviction records.