Offer summary
Qualifications:
BA/BS degree in science or equivalent experience, 5+ years’ experience in quality functions in medical devices, Experience with FDA cGMP/QSR and ISO 13485, Proficient in Microsoft Office applications, Arena experience preferred.
Key responsabilities:
- Ensure company and customer quality standards are met
- Maintain quality system in accordance with ISO 13485
- Manage compliance activities for complaints and CAPA processes
- Support internal audits and regulatory compliance activities
- Coordinate supplier management and post-market surveillance