Quality Engineer II

Kelly Services currently has an opportunity for a Quality Engineer II in West Chester, PA with a prestigioous medical device design and development company. 

Duration: 6 months +

Pay Range: $35-$36/hour

Description:

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 micn083@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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

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