Vacancy expired!
Class III medical device client focusing on neurostimulation devices is looking to bring on a Director of Quality to their growing team, fully on site in San Diego, California. The team is committed to finding solutions for managing chronic mechanical pain with sites globally in efforts to provide patients with lasting or meaningful relief.
The team is seeking out a highly driven and hands-on Quality Assurance Director who will be responsible for the maintenance and management of the Quality Management System to ensure it is up to QA standards. This person will serve as the primary point of contact for all FDA and Notified Body inspectors and auditors for on site inspections and audits. Position Responsibilities:- Responsible for maintaining the Quality Management System
- Internal Audit
- CAPA
- Design Quality
- Supplier Quality
- Operations Quality
- Manage Change Control Systems
- Oversee Project teams to ensure Design Control and product requirements are met
- Manager Design Verification and Validation protocols
- Experience in managing Quality Professionals for up to 5 years
- 10 years of experience within Quality within medical device
- Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971
- Lead Auditor Certified
- Hands on and positive attitude as the lead QA representative
- Competitive base salary
- Bonus Component
- RSU's
- Medical, Dental, and Vision Coverage
Vacancy expired!