What are the responsibilities and job description for the Supplier Quality Engineer position at BioTalent?
Supplier Quality Engineer – Medical Device Industry
📍 Camarillo CA – United States
Must be authorized to work. No relocation US Citizen or Green Card holder
About the Role
A growing medical device manufacturer is seeking a Supplier Quality Engineer (SQE) to ensure that externally sourced materials, components, and services meet applicable regulatory, quality, and performance requirements. This role partners cross-functionally with Supply Chain, Manufacturing, R&D, and Regulatory Affairs to qualify, monitor, and continuously improve supplier performance in compliance with FDA 21 CFR Part 820 (QMSR), ISO 13485, and other global regulatory standards.
Qualifications
- Bachelor's degree in Engineering, Biological Sciences, Quality, or related technical discipline
- Minimum 5 years of quality experience in the medical device industry
- Strong knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485, ISO 14971, CAPA systems, and supplier auditing practices
- Experience conducting supplier audits independently
- Experience managing SCARs and supplier performance metrics
- Strong technical writing and analytical skills
- ASQ Auditor or Lead Auditor certification for ISO 13485 preferred
Key Responsibilities
Supplier Qualification & Onboarding
- Lead supplier selection and qualification activities including on-site and remote audits, quality system assessments, and technical capability evaluations
- Approve supplier validation documentation and quality agreements
- Establish supplier quality requirements and acceptance criteria
- Ensure suppliers meet ISO 13485 and FDA QSR/QMSR expectations
Supplier Auditing & Oversight
- Plan and execute supplier audits in accordance with risk-based audit schedules
- Evaluate compliance to 21 CFR Part 820, ISO 13485, ISO 14971, and sterilization standards (ISO 11135/11137) as applicable
- Document audit findings and drive timely corrective actions
- Assess supplier readiness for regulatory inspections
Supplier Performance Monitoring
- Establish and maintain supplier scorecards and KPIs
- Analyze supplier quality trends (PPM, NCRs, SCARs, OTD)
- Drive continuous improvement initiatives with suppliers
- Conduct quarterly business reviews as needed
Nonconformance & CAPA Management
- Lead supplier corrective action requests (SCARs)
- Investigate supplier-related nonconformances and complaints
- Perform root cause analysis (5-Why, Fishbone, etc.)
- Verify effectiveness of corrective and preventive actions
- Escalate critical quality issues appropriately
Validation & Change Management
- Support supplier-related validation activities including process validation (IQ/OQ/PQ), sterilization validation oversight, and packaging validation
- Review and approve supplier change notifications
- Perform risk assessments for supplier changes
- Ensure compliance with biocompatibility, material, and regulatory requirements
- Support regulatory submissions requiring supplier documentation
Risk Management
- Participate in supplier risk assessments
- Support DFMEA/PFMEA related to supplied components
- Ensure critical suppliers are identified and controlled appropriately
Cross-Functional Collaboration
- Partner with Engineering during new product development and Operations during scale-up and product transfer
- Provide supplier quality input during design reviews
Work Authorization:
This role requires current authorization to work in the United States. We are unable to provide visa sponsorship now or in the future
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