What are the responsibilities and job description for the Senior Quality Assurance Engineer position at BioTalent?
Our client is seeking a Senior Quality Engineer to join their team and drive excellence in quality and compliance for class I-II medical devices. This role requires a strong background in global medical device regulations, including EU MDR and FDA requirements.
Key Responsibilities :
- Ensure compliance with EU MDR, FDA 21 CFR Part 820, ISO 13485, and other global regulations.
- Lead quality system improvements, including CAPA, audits, and process validation.
- Provide regulatory guidance on design controls, risk management, and post-market surveillance.
- Collaborate with cross-functional teams to ensure regulatory and quality compliance in product development and manufacturing.
- Support internal and external audits, including FDA and notified body inspections.
Qualifications :
On Offer :
This is a great opportunity to make a direct impact on patient safety and regulatory compliance in a growing, innovative medical device company.
