Supplier Quality Engineer leading Preventive Quality projects and ensuring compliance with AS9145 standards at Boeing. Collaborating with suppliers and internal teams to optimize product deliverables.
About the role
- Quality Assurance Manager responsible for leadership in Quality Management Systems at a biotech company. Ensuring compliance, scalability, and driving culture of quality improvement.
Responsibilities
- Provide day-to-day leadership for Quality Management System (QMS) processes and the Quality team
- Ensure continued suitability, compliance, and scalability of the QMS
- Drive a culture of quality, proactive risk management, and continuous improvement
- Own assigned QMS processes end-to-end
- Oversee systems/process validation activities
- Lead investigations for deviations, nonconformances, and complaints
- Plan and execute internal audits
Requirements
- Bachelor's Degree in Biology, Chemistry, Life Sciences, Engineering, or related field (required)
- 8+ years of experience in quality supporting clinical research and/or pharmaceutical/biotech development
- 3+ years of experience leading others
- Demonstrated expertise in QMS processes
- Demonstrated experience with Computer System Validation (CSV) in a regulated environment
- Regulatory/quality certifications (ASQ/SQA) and/or Lean/Six Sigma preferred
- Strong computer literacy
Benefits
- Health insurance and wellness programs
- Professional development opportunities
- Paid time off
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