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