Quality Assurance Manager
On-siteNorristown, Pennsylvania, United States
Norristown, Pennsylvania, United StatesOn-siteFull TimeSenior LevelBachelors Degree
Full TimeSenior LevelBachelors Degree
Job Summary
Quality Assurance Manager responsible for managing quality and regulatory compliance for assigned products and processes at manufacturing sites. Lead site Quality and Compliance governance, oversee QA/QC staff, conduct internal/external audits, manage CAPA and deviation processes, drive root cause investigations, and align quality goals with manufacturing KPIs while coordinating with regulatory, suppliers, and operations to ensure product quality and customer satisfaction.
Required Qualifications
- Bachelor’s degree in Engineering, Science, or Technical Field
- 4+ years of experience related to the manufacturing of medical devices and/or drug/cosmetic product platforms
- Experience with design controls, risk management, and compliance with QSR/GMP/ISO requirements
- Experience supervising or managing QA/QC/Laboratory staff in support of Device/Drug/Cosmetic Manufacturing or other similarly regulated industries
- Strong knowledge of FDA regulations, ISO 13485, and industry best practices
- Exceptional writing, proofreading, and documentation skills
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