BioTalent is partnered with a medical device manufacturer focusing on medical and clinical equipment to hire a Quality Assurance Manager. You will be adopting a team of 5+ direct reports while managing new product development as they make improvements to an already established product.

Responsibilities

• Develop, implement, and maintain the QMS in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations and standards.
• Plan, conduct, and oversee internal and external audits to ensure compliance with the QMS and regulatory requirements.
• Implement corrective and preventive actions (CAPA) to address identified non-conformances and opportunities for improvement.
• Conduct supplier audits and manage supplier performance. Screen and select new suppliers when applicable.
• Develop and deliver quality-related training programs to employees, ensuring a thorough understanding of quality policies and procedures.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards.
• 5+ years in a management position with direct reports.
• Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) credentials are a plus.
• Highly organized with excellent attention to detail