- Location: Raleigh, NC
- Working situation: Hybrid
- Level: Director
- 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.
- 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.
- 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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Director of Quality – Med Device - North Carolina, United States - EPM Scientific
Description
Director of Quality – Med Device
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:
The Director – Quality Assurance has the following qualifications:
Company Benefits:
