Director, Quality Assurance - Customer Quality Experience & QMS
Director, Quality Assurance – QMS & Customer Quality
The Director, Quality Assurance - QMS will lead our Quality Assurance team in maintaining and enhancing our ISO 13485-certified QMS. The ideal candidate will have a proven track record of success in managing and executing QMS activities, ensuring compliance with regulatory requirements, and resolving customer complaints. They will also have deep expertise in ISO 13485, genomics, and hands-on experience in conducting internal and external audits. The Director of Quality Management System at Twist is responsible for building and maintaining the Twist Quality Management System (QMS). This individual designs quality programs that will satisfy customer requirements for each individual product line. The QA Director is responsible for achieving and maintaining the appropriate ISO and/or regulatory certifications for each business unit.
What You’ll Be Doing
- Lead and manage a team of Quality Assurance specialists responsible for all aspects of the QMS, including corrective and preventive actions (CAPA), and audits.
- Develop and implement comprehensive QMS procedures to ensure compliance with ISO 13485 and other applicable regulatory requirements.
- Conduct internal and external audits to identify and address potential QMS non-conformities.
- Investigate and resolve customer complaints in a timely and effective manner.
- Manage the CAPA process to ensure that all non-conformities are identified, investigated, and resolved promptly.
- Stay up-to-date on the latest industry trends and regulatory changes in the genomics field.
- Provide training and mentorship to Quality Assurance team members on QMS principles, ISO 13485, and regulatory compliance.
- Manage local and global Complaint Handling and Audit Team
- Ensure maintenance of job descriptions
- Build and maintain a CAPA system
- Achieve and maintain 13485:2016 certification as appropriate per product line
- Achieve and maintain 9001:2015 certification as appropriate per product line
- Oversee QMS compliance for all personnel and disciplines
- Ensure supplier quality objectives are met
- Establish and maintain an internal audit schedule
- Conduct internal audits
- Establish product development lifecycle with appropriate design controls
- Establish SW development lifecycle with appropriate design controls
- Build and maintain a change control system
- Establish monitoring and measuring systems
- Create customer complaint and feedback tracking
- Implement continuous improvement
What You’ll Bring to the Team
- Master's degree in Quality Assurance, Regulatory Affairs, or a related field.
- Minimum of 10 years of experience in the medical device or biotechnology industry, with a strong focus on QMS and ISO 13485 compliance.
- Proven experience in developing and implementing QMS procedures and conducting internal and external audits.
- Deep expertise in ISO 13485, genomics, and regulatory compliance.
- Experience in resolving customer complaints and managing the CAPA process.
- Excellent communication, collaboration, and leadership skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Hands-on experience with QMS management software.
- S. in Biochemistry, Molecular Biology, Microbiology, Bioengineering, or related field and fifteen years of experience in the area of technology transfer
- At least 10 years GxP experience
- Ability to communicate effectively both verbally and in writing
- Demonstrated knowledge of product development lifecycle, including the ability to guide large-scale programs toward commercialization goals
- Strong supervisory and organizational abilities
- Demonstrated experience in product commercializing