Senior Quality Assurance Manager
Location: North Carolina
Working Situation: Hybrid
Level: Mid-Senior level Associate
Our client, a Mid-sized medical device firm, is working to produce class 1 and 2 medical devices used to enhance the quality of care for medical professionals. Senior Quality Assurance Manager The Senior Quality Assurance Manager will play a critical role responsible for overseeing the company's Quality Assurance activities, ensuring compliance with regulations. The Senior Quality Assurance Manager will play a key role in shaping the future of medicine by contributing to the development of class 1-2 medical devices to enhance the quality of care throughout the medical field
The Senior Quality Assurance Manager will:
- Execute Quality Continuous improvements for the Quality Assurance Team.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Monitor and trend data while assembling reports on product release test monitoring of company cGMP facility.
- Frequently update stakeholders on trends.
- Implement corrective action plans when vital.
- Tracking of data from external contract manufacturers and laboratories to complete lot disposition.
The Senior Quality Assurance Manager will:
- 2+ years of people management experience (required).
- 5+ years of experience working with quality management system (desired).
- Bachelors Degree with relevant fields with 4+ years of medical device industry experience.
Company Benefits:
- A competitive salary and stock option plan along with a range of benefits
- PTO, company health care plan, medical, dental, and vision insurance
- Short and long-term disability insurance, life insurance policy
- 401k
- opportunities for continuing education.
