Role OverviewWe 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.
What You Will Do
Implement and maintain QMS procedures, own internal and external audit program, manage local and global audit team, own quality training program, lead Quality Assurance initiatives, and oversee QMS compliance.
Why It Might Be a Fit
The ideal candidate brings deep ISO 13485 expertise, hands-on audit experience, and a strong understanding of the genomics or life sciences space.
Requirements
- Bachelor's degree in Engineering, Physical/Life Sciences, or a related field (Master's preferred)
- 7+ years of experience in the medical device or biotechnology industry, with a strong focus on QMS and ISO 13485 compliance
- Proven experience developing and implementing QMS procedures and conducting internal and external audits
- Working knowledge of ISO 13485, genomics, and regulatory compliance
- Hands-on experience with QMS management software
- Experience with the product development lifecycle and product commercialization
- Strong supervisory, organizational, analytical, and problem-solving skills
- Excellent written and verbal communication, collaboration, and leadership skills
- Ability to work independently and on a team in a fast-paced environment
Benefits
- Bonus
- Equity
- Generous benefits package
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