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17 days old

Supplier Quality Engineer

Kelly Services
Bridgewater, MA 02324
_Kelly Engineering/OCG is currently seeking a_ **_Supplier Quality Engineer_** _for a project engagement at one of our Global clients in_ **_Bridgewater, MA._**


_This role is a full-time, fully benefitted position._


_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 Kelly Engineering/OCG employees receive annual performance reviews._


_As a_ **_Supplier Quality Engineer_** _placed with Kelly Engineering/OCG you will be responsible for the following:_


**_OVERALL RESPONSIBILITIES:_**


_The Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Customer products. The Supplier Quality Engineers primary responsibility will be to manage the approved supplier list (ASL) processes and will work in developing quality engineering skills as it relates to supplier quality management tasks._


**_POSITION DUTIES & RESPONSIBILITIES:_**


+ _The Supplier Quality Engineer will conduct audits to good manufacturing practices, international_ _organization for standardization and any other applicable standards._

+ _Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes._

+ _This individual will utilize multifaceted industry and process excellence standards in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO)._

+ _Address and correct product and process complaints._

+ _Report on contract manufacturer performance metrics and management reviews._

+ _This individual will oversee audits of all quality system categories to assess compliance to process excellence standards._

+ _Ensure comprehensive measurement systems to monitor effectiveness of quality and_ _reliability systems to identify, bracket, correct and prevent defects, presenting reports to management._

+ _Handle technical issues for manufacturing processes that are to be transferred to satellite_ _facilities._

+ _Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management._

+ _FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus._


**_EDUCATION & EXPERIENCE REQUIREMENTS:_**


+ _A minimum of a Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred._

+ _A minimum of 2 years of experience in a GMP and/or ISO regulated industry is required._

+ _Experience in the medical device and/or pharmaceutical industry is preferred._

+ _Both, FDA and ISO regulations knowledge._

+ _FDA CFR Part 820 and/or ISO 13485 knowledge._

+ _Strong communication, teamwork, and problem-solving skills._

+ _Prior experience working collaboratively in a highly matrixed organization._

+ _Intermediate knowledge and use of Microsoft office._

+ _Six Sigma, Lean, or ASQ Certification and trainings._


**_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** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**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 (plus, did we mention we provide a ton of benefits ?). 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-10-08 Expires: 2021-11-25

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Supplier Quality Engineer

Kelly Services
Bridgewater, MA 02324

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