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18 days old

Quality Engineer - FDA

Kelly Services
Raynham, MA 02767
**Kelly Services is currently looking to hire a** **Quality Engineer with previous FDA industry expereince** **for one of our top Medical Device customers in Raynham, MA -** **R** **elocation reimbursement is not offered for this role**




**Summary:**


**Working in a team setting, this individuals major responsibilities will be as follows (but not limited to):**


**Support legacy products and design through design control activities.**


**Learn surgical procedures and map the product solutions into potential areas of risk and liability.**


**Support and conduct process verification and validation activities.**


**Conduct and lead process/design/procedural failure mode effects and analysis.**


**Develop risk assessment; inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams.**


**Conduct audits of new suppliers as part of the new product development project teams.**


**Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions.**


**Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Nonconforming Materials, Risk Management, etc.**


**Provides leadership in the understanding of Medical Device (21 CFR 820) regulations to other disciplines.**


**Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.**


**This individual will work in a team setting to provide leadership and support throughout the product lifecycle.**


**This individual should be willing to make a significant contribution to a multi-disciplinary team, must be self-motivated and have excellent written and verbal communication skills.**




**Qualifications:**


**A minimum of a Bachelor's degree in a Scientific discipline is required. An advanced degree in a related field is an asset.**


**Quality Engineering experience required with a minimum of 4 years of work experience in the Medical Device industry preferred.**


**Excellent problem solving and decision-making skills will be required. Interpersonal skills that foster conflict resolution as it relates to technical situations will be required.**


**Advanced Technical Training in Quality Engineering principles, Risk Management, Product Testing, and Sports Medicine is preferred.**


**Knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, and any other specific product standard is an asset.**


**Experience conducting Process / Design Failure Mode Effects and Analysis is required.**


**Experience leading Process Verification / Validation activities is required.**


**Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and techniques is an asset.**


**Process Excellence/Lean experience is preferred.**


**This position will be based in Raynham, MA.**




**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 immediately and without employer sponsorship (** **F1 OPT/H1B** **cannot be considered for this position).**



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



Kelly puts you in charge of your career, with access to cutting edge projects and technologies in
industry leading organizations. Top companies throughout the world have trusted Kelly as a premier
source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm
with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety
and flexibility of working on short term project engagements, or prefer contract-to-hire or direct
hire placement with our clients, apply with Kelly to explore opportunities that suit your specific
professional interests.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-08-02 Expires: 2019-09-02

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Quality Engineer - FDA

Kelly Services
Raynham, MA 02767

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