Senior Quality Assurance Manager

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.