What are the responsibilities and job description for the Quality Engineer position at BioTalent?
Job Title: Supplier Quality Engineer
Department: Quality
Reports To: Head of Quality / Quality Leadership
Job Summary
The Supplier Quality Engineer (SQE) is responsible for ensuring that externally sourced materials, components, and services meet applicable regulatory, quality, and performance requirements within a regulated manufacturing environment. This role partners cross-functionally with Supply Chain, Manufacturing, R&D, and Regulatory teams to qualify, monitor, and continuously improve supplier performance in compliance with applicable global quality and regulatory standards.
Key Responsibilities
Supplier Qualification & Onboarding
- Lead supplier selection and qualification activities, including:
- Supplier audits (remote and on-site)
- Quality system assessments
- Technical capability evaluations
- Review and approve supplier documentation and quality agreements
- Define supplier quality requirements and acceptance criteria
- Ensure supplier compliance with applicable regulatory and quality standards
Supplier Auditing & Oversight
- Plan and execute supplier audits based on risk
- Evaluate supplier compliance to applicable regulations and standards
- Document audit findings and drive corrective actions
- Assess supplier readiness for regulatory inspections
Supplier Performance Monitoring
- Develop and maintain supplier scorecards and KPIs
- Analyze supplier quality metrics (e.g., defects, nonconformances, delivery performance)
- Drive supplier continuous improvement initiatives
- Participate in periodic supplier performance reviews
Nonconformance & CAPA Management
- Lead supplier corrective action processes
- Investigate supplier-related nonconformances and complaints
- Perform root cause analysis (e.g., 5 Whys, Fishbone)
- Verify effectiveness of corrective and preventive actions
- Escalate critical issues as needed
Validation & Change Management
- Support supplier-related validation activities, including:
- Process validation (IQ/OQ/PQ)
- Sterilization and packaging validation (if applicable)
- Review and assess supplier change notifications
- Conduct risk assessments for supplier changes
- Ensure proper implementation through change control processes
- Support regulatory documentation as needed
Risk Management
- Participate in supplier risk assessments
- Support risk management activities (e.g., FMEA)
- Identify and manage critical suppliers
Cross-Functional Collaboration
- Partner with Engineering on new product development
- Support Operations during scale-up and product transfers
- Provide supplier quality input during design reviews
Qualifications
Education
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field
Experience
- 5 years of quality experience in a regulated industry (e.g., medical device, biotech, or similar)
- Strong knowledge of quality systems, regulatory requirements, and risk management
- Experience conducting supplier audits independently
- Experience managing supplier corrective actions and performance metrics
- Strong analytical and technical writing skills
Preferred
- Professional certification (e.g., quality auditor or lead auditor)
Salary : $85,000 - $95,000