QA/QC Director responsible for strategic leadership and operational oversight in a biotech facility. Leading QA and QC functions supporting cell and gene therapies with FDA compliance.
About the role
- Quality Assurance Manager ensuring compliance in medical device quality assurance. Developing processes and leading audits for quality improvement in the field.
Responsibilities
- Develop and implement quality assurance processes
- Collaborate with cross-functional teams to identify and resolve quality issues
- Conduct audits and inspections to ensure compliance with regulations
- Lead post-market surveillance and customer feedback analysis
Requirements
- 5+ years of experience in quality assurance
- Strong knowledge of quality assurance methodologies
- Familiarity with automated testing tools
- Experience in a medical device field preferred
- Bachelor’s degree in a relevant field
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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