1+ months

Quality Engineer-Medical Device

Kelly Engineering Resources
Raynham, MA 02767
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  • Job Code
    US41T8NM_BH2953172
Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and a business unit of Kelly Services, Inc., is currently seeking a Quality Engineer III - Medical Device  for a long-term engagement at one of our Global clients in Raynham,MA.

 

This role is a full-time, fully benefitted position. As a KellyOCG employee, you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from.

You’ll also be eligible for paid time off, including holiday, vacation and sick/personal time.

 

All KellyOCG employees receive annual performance reviews.

 

The Quality Engineer III – Medical Device

Quality Engineer III should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. 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.  Working in a team setting, this individual’s 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.



Qualifications


A minimum of a Bachelor's degree in a Scientific discipline is required.  An advanced degree in a related field is an asset. 
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.
A minimum of 4 years of work experience in the Medical Device industry is required. 
Quality Engineering experience is 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.


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®?
As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.



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.#KellyGTS]]
Posted: 2020-07-11 Expires: 2020-12-04
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Quality Engineer-Medical Device

Kelly Engineering Resources
Raynham, MA 02767

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