Manager, Quality Management Systems
Twist Bioscience
Twist Bioscience seeks an experienced Manager of Quality Management Systems to build and maintain ISO 13485 compliance across the organization. The role encompasses audit program oversight, quality training development, regulatory support, and QMS governance across all product lines in the genomics space.
Responsibilities
- Implement and maintain ISO 13485:2016 compliant QMS procedures across product lines
- Own internal and external audit program including scheduling, execution, and nonconformity resolution
- Develop and manage quality training curriculum with completion tracking across all disciplines
- Lead QA initiatives focused on audit, training, and compliance improvement
- Mentor QA team members on QMS principles, ISO 13485, and regulatory requirements
Requirements
- Bachelor's degree in Engineering, Physical/Life Sciences, or related field; Master's preferred
- 7+ years medical device or biotechnology industry experience with ISO 13485 focus
- Proven track record developing and implementing QMS procedures and conducting audits
- Working knowledge of ISO 13485, genomics, and regulatory compliance
- Hands-on experience with QMS management software
- Experience with product development lifecycle and commercialization at scale
- Strong supervisory, analytical, and problem-solving capabilities
Vacancy posted 2 days ago
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