16 days old

Quality Engineer

Kelly Services
Raynham, MA 02767
KellyOCG, a managed solution provider and business unit of Kelly Services, is currently seeking **Quality Engineers** for a long-term engagement at a premier client in **Raynham, MA.**

As a **Quality Engineer** placed with Kelly Services you will be responsible for the following:

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

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.

**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.


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.

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

+ Vacation and sick pay

+ Paid holidays

+ 401(k) plan

+ Group medical, vision, dental, life, and short-term disability insurance options

+ Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools

+ Kelly Learning Center offers free courses and trainings

+ Weekly pay

**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.

**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. 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
Posted: 2019-10-28 Expires: 2019-11-28

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Quality Engineer

Kelly Services
Raynham, MA 02767

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