Senior Quality Manager Med Device
3 days ago
Senior Quality Manager Med Device
- Location:Atlanta, GA
- Working situation: Hybrid
- Level: Director
Our client, a large and well-known medical device company producing primarily Class II & Class III devices, is looking to add to their Quality team
The Senior Quality Manager Med Device will help lead the Quality department and oversee all aspects of Quality Assurance, bit with a heavy focus on leading the Quality Engineering group. This individual will work to foster a culture of quality through providing leadership and guidance to their team and company.
The Senior Quality Manager Med Device will:
- Establish and maintain quality management systems (QMS) in accordance with ISO 13485 and other relevant standards.
- Identify, direct, and monitor 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.
- Be 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 Senior Quality Manager Med Device has the following qualifications:
- Bachelors Degree in Biology, Chemistry, Engineering, or related fields.
- Minimum of 10 years of Quality experience in the Med Device industry 5-7 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 terms of equity or stock at this level
- Flexible hybrid working model
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