Manager, Quality Management Systems

We are looking for an experienced Manager of Quality Management Systems to build, maintain, and improve our ISO 13485-certified QMS. In this role, you will own our internal and external audit program and our quality training program. You will keep the QMS compliant across all disciplines and support regulatory initiatives. You will also design and maintain quality programs that meet customer requirements for each product line. The ideal candidate brings deep ISO 13485 expertise, hands-on audit experience, and a strong understanding of the genomics or life sciences space.

What You’ll Do

• Implement and maintain QMS procedures that comply with ISO 13485:2016 and other applicable regulations, and support certification across product lines.
• Own the internal and external audit program. This includes setting the audit schedule, conducting audits, and identifying and resolving nonconformities.
• Manage the local and global audit team.
• Own the quality training program, including curriculum development, training assignments, and completion tracking across all disciplines.
• Lead Quality Assurance initiatives and projects focused on audit, training, and compliance.
• Oversee QMS compliance for all personnel and functions.
• Make sure supplier quality objectives are met.