Job Position Summary:
The Quality /Regulatory Manager shall be responsible for “hands-on” oversight and continued implementation of the Company’s existing Quality Management System (QMS) certified to ISO 13485:2016 and meeting the MDSAP regulatory requirements for the US and Canada and certification to ISO 9001:2015. The Quality /Regulatory Manager shall report directly to the Company’s senior manager. In the capacity, they shall ensure that:
1. The Company’s Quality System manual and all subordinate processes fulfill all applicable ISO standards and regulatory requirements.
2. All employees are fully trained and understand the contents of the Company’s Quality System manual and all processes relevant to their job descriptions.
3. Company quality objectives are established, understood, measurable, and accomplished.
4. A risk management program is implemented, appropriate control measures established, and a risk management plan developed for each Company project.
5. All product and service suppliers / key suppliers have been qualified and approved.
6. Records of work performed by all employees shall be documented in accordance with the requirements specified for each process performed.
7. The design and development processes regarding all Company products are adhered to, documented, and records demonstrating compliance are generated and retained.
8. Product and process nonconformities are documented, investigated, analyzed, and dispositioned in accordance with a preventive / corrective action plan which has been approved.
9. Company processes are monitored and measured for effectiveness.
10. Quality auditing is scheduled and performed in accordance with schedule requirements.
11. Management reviews are performed annually
12. UDI labeling and GUDID information for medical devices marketed and sold in the United States comply with 21CFR Part 830.
13. All annual FDA and Health Canada reporting requirements are complied with per regulatory specified deadlines.
Education and Experience:
1. Minimum of a bachelor’s degree in engineering or an applicable life science discipline.
2. Minimum five (5) years “hands-on” experience developing, implementing, and maintaining ISO 13485 and MDSAP (US and Canada) requirements.
3. Experience working with and managing external auditing bodies and representing the Company at these audits.
4. Highly goal-oriented, "hands-on" professional who can interact effectively with personnel at all levels; and possess a proven track record of active involvement in a Company’s daily operations.
5. Experience working on projects consisting of large, custom designed medical devices that are designed for multiple use.
6. Demonstrated experience in establishing, implementing, and administering electronic-based Quality Management Systems (e-QMS); particularly Quality Collaboration By Design (QCBD).
Job Type: Full-time
Pay: $75,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Flexible spending account
- Health insurance
Schedule:
Ability to Relocate:
- San Diego, CA 92154: Relocate before starting work (Required)
Work Location: In person