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Kelly Services Quality Engineer in West Chester, Pennsylvania

Kelly Services currently has an opportunity for a Quality Engineer with a prestigious medical device company, located in West Chester, PA

Location : West Chester, PA

Duration : Through December, 2019 or longer

Pay Range: $35-$36/hour

Description :

OVERALL RESPONSIBILITIES:

  • 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.

    POSITION DUTIES & 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.

  • As needed, be key interface to ensure events are escalated in a timely manner and per procedure.

  • Gather data working and preparing response for the US and international regulatory agencies

  • Provide daily support to the Complaint Teams and ensure complaint investigations are robust and well documented.

  • Assist in training and mentoring of new employees, provide guidance and direction to peers, and serve as an expert in the investigation process.

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

  • Other duties as assigned.

    PROFESSIONAL EXPERIENCE REQUIREMENTS:

  • A minimum of 4 years experience in a GMP and/or ISO regulated environment.

  • Medical device industry preferred

  • Previous root cause analysis skills is required.

  • Experience conducting and reviewing complaint investigations highly preferred.

  • Project management experience preferred

  • Ability to collaborate with business partners at all levels is required.

  • Knowledge of process and design excellence tools preferred.

  • Proficiency with Microsoft Office Suite required.

  • Knowledge of CAD software highly preferred.

  • Excellent communication and presentation skills required.

  • This position may require up to 10% travel, including light international travel. This role will be based in West Chester, PA and does not offer relocation benefits.

    EDUCATIONAL REQUIREMENTS:

  • A minimum of Bachelor’s Degree in Engineering is required.

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 apply online or contact luisa.ruthner@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.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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