Director of Quality
2 weeks ago
Director of Quality – Med Device
Location : Raleigh, NC
Working situation : Hybrid
Level : Director
Our client, a mid-sized medical device company producing Class II & Class III devices, is looking to add to their Quality team
The
Director – Quality Assurance
will help lead the Quality department and oversee all aspects of Quality Assurance. This individual will work to foster a culture of quality through providing leadership and guidance to their team and company.
The Director – Quality Assurance will:
Establish and maintain quality management systems (QMS) in accordance with ISO 13485 and other relevant standards.
Identify, direct, and monitoring FDA and ISO audits, both internal and external, and assist with supplier audits
Manage and mentor Quality management staff to promote personnel development and succession planning.
Responsible for reviewing and delivering Quality Budget
Collaborate cross-functionally with R&D, manufacturing, clinical affairs, and other departments to support product development, manufacturing, and commercialization activities.
Drive a culture of quality and regulatory compliance throughout the organization, promoting awareness and understanding of quality and regulatory requirements among all employees.
The Director – Quality Assurance has the following qualifications:
Bachelor’s Degree in Biology, Chemistry, Engineering, or related fields
Minimum of 10 years of Quality experience in the Med Device industry 7-10 years of management experience
In-depth knowledge of relevant regulations and standards, including FDA QSR, ISO 13485, MDR, and other global regulatory requirements.
Strong leadership and management skills, with the ability to inspire and motivate teams to achieve results.
Company Benefits:
Competitive 401K program, health insurance, and HSA accounts
Long term incentives in the terms of equity or stock at this level
Flexible hybrid working model
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