Director of Quality

3 weeks ago

Atlanta, United States EPM Scientific Full time

Director of Quality - Med Device Location:

Raleigh, NC Working situation:

Hybrid Level:

Director Our client, a large, successful med device company and 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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