Offer summary
Qualifications:
Bachelor’s degree in Quality Assurance, Regulatory Affairs, or related field., Minimum 5 years of QA experience with focus on FDA-regulated industries., Strong knowledge of FDA regulations and quality standards..
Key responsabilities:
- Develop/implement QA processes and ensure compliance with FDA regulations.
- Lead/manage QA team, oversee test plans, audits, and reviews.
- Collaborate across functional teams to meet quality requirements.
- Stay updated on FDA regulations, identify risks, and develop mitigation strategies.