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22 days old

Quality Engineer-Medical Device

Kelly Services
Raynham, MA 02767
**_Kelly Outsourcing & Consulting Group (KellyOCG)_** _, a managed solution provider and a business unit of_ **_Kelly,_** _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._



_Youll 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 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._




**_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 7-10 years of work experience in the Medical Device industry is required._**

+ **_A minimum of 7-10 years 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, DFMEA._**

+ _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: 2020-07-13 Expires: 2020-08-27

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Quality Engineer-Medical Device

Kelly Services
Raynham, MA 02767

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