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Job ID :
48046BR
Location :
US - California - Fremont
:
Job Description

Position Summary:

Lead nonconformance investigations and material review board discussion. Review nonconformance report and complaint report, Provide guidance for quality requirement. Approve Nonconformance Report.

Key Responsibilities:

  • Review nonconformance request, customer complaints.
  • Perform the risk assessments and evaluate product impact.
  • Conduct Nonconformance investigations to understand issues and identify root causes.
  • Review and approve investigating plan and corrective and preventative action plans.
  • Assist root cause investigation.
  • Ensure Quality documentation is in compliance with TFS SOPs and Regulation requirement.
  • Write Nonconformance documents and reports
  • Write and revise SOPs as needed
  • Conduct training for Quality process.
  • Lead Nonconformance investigation activities and coordinate material board review meetings.

Minimum Requirements/Qualifications:

  • Minimum BS, 7+ years experience or MS 5+ years experience in Chemistry, Biochemistry, and Biology related field, preferably with quality/technical operation experience in IVD industry.
  • Understand Regulation Requirement for IVD products.
  • Understand Clinical Chemistry products, production process and documentation requirements.
  • Experience investigating nonconforming events using basic statistical and data analysis skills.
  • Experience participating on and leading cross-functional teams.
  • Excellent organizational and multi-tasking skills.

Non-Negotiable Hiring Criteria:

  • This position does not offer Relocation Assistance.
  • Thorough understanding of 21CFR 820 and ISO 13485 regulations for medical devices.
  • Excellent writing and verbal communication skills.
  • Experience in risk assessment/management.




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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