Post market surveillance Quality Engineer

3 weeks ago

Irvine, United States TalentBurst, Inc. Full time

Position: Post market surveillance Quality Engineer, Req#: 6223-1
Location: Irvine, CA  (100% onsite)
Duration: 8 Months Contract

Job Description: 

Perform Post Market customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities to establish corrective and preventive actions. Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner. Oversight of all complaints that require investigation through the different phases. Ensure on-time completion of complaints. Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed. Ensure complaint investigations are adequate and comply with applicable procedures.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the job description for additional details.

Education and Experience: 

  • Bachelor's Degree in Engineering or Scientific field including either industry or industry/education, a minimum of 2 years of experience Required

Or

  • Master's Degree or equivalent in Engineering or Scientific field including either industry or industry/education Required or internship, senior projects, or thesis Required.

Required Skills: 

  • Proficient in MS Suite, especially Excel and PowerPoint
  • Experience with Power BI
  • Understanding of data trending and analytics, data pulls/refresh data sources
  • Post market surveillance experience
  • General background/understanding of Post Market Analysis:
  • Complaints
  • FCA
  • PRA
  • CAPA
  • Understanding of regulations, a plus; EUMDR, FDA, ISO standards
  • Medical device experience
  • Excellent writing skills
  • Ignite preferred
  • ETQ (Reliance) experience preferred

 

Roles and Responsibilities: 

  • Investigate moderately complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes before final product release based on engineering principles; analyze results, make recommendations, and develop reports.
  • Develop, update, and maintain technical content of risk management files
  • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
  • Assign support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
  • Other incidental duties assigned by Leadership
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