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3 days old

Quality Engineer

Kelly Services
West Chester, PA 19381
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!





**Title:** Quality Engineer



**Location:** West Chester, PA



**Duration:** 9 months **Overview**




+ Primary responsibilities include activities associated with conducting complaint investigations including: triage of incoming complaints, documenting requirements for evaluations and investigations, conduct of investigations and communications of performance and safety issues.

+ Initiate and lead projects involving failure investigations, root cause analysis using appropriate investigative techniques and statistical methods.

+ Summarizing the results of data analysis and investigations into clear, concise complaint documentation and presentations and reports for peers, cross-functional teams and management. Support business partner processes in post market surveillance, customer quality regulatory reporting, operations/operations quality and new product development.

+ Operates in a safe, effective, and professional manner compliant to all policies, procedures, and regulations including health and safety.





**Responsibilities**




+ Triage incoming complaints.

+ Document requirements for investigations.

+ Investigate customer complaints for product quality issues.

+ Lead projects involving failure investigations. Root cause analysis.

+ Utilize statistical tools to analyze complaints and corrective actions.

+ Participate in HHEs as required.

+ Work with manufacturing, R&D, Medical Affairs, and international affiliates as required.

+ Summarize results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management.

+ Summarize data to support post market surveillance, regulatory responses, etc.

+ Interface with key business partners including R&D, Operations, Post Market Risk Management and Surveillance, Quality, Regulatory and Compliance, to insure complete and thorough investigations.

+ Conduct user interviews and manufacturing and R&D visits to ensure rapid response to field safety issues.

+ Participate on CAPA teams and acting as CAPA Action and Internal Audit task owner.





**Required Qualifications**




+ Bachelors Degree in Engineering.

+ Minimum of 4 years experience in a GMP and/or ISO regulated environment.

+ Previous root cause analysis skills.

+ Ability to collaborate with business partners at all levels.

+ Proficiency with Microsoft Office Suite.

+ Excellent communication and presentation skills.

+ May require up to 10% travel, including light international travel.





**Preferred Qualifications**




+ Medical device industry.

+ Experience conducting and reviewing complaint investigations.

+ Project management experience.

+ Knowledge of process and design excellence tools.

+ Knowledge of CAD software.





**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. Please contact Taryn Carbone ( taryn.carbone@kellyservices.com ) for immediate consideration.




**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: 2019-11-08 Expires: 2019-12-09

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Quality Engineer

Kelly Services
West Chester, PA 19381

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