The Senior Specialist, Quality Systems is a key member of the Quality Assurance function, as well as across the Synthetic Biology Solutions Business Area.
- Complies with departmental procedures and policies and appropriate Quality policies.
- Responsible for supporting development and implementation of the Quality Management System (QMS) and supporting infrastructure/tools in compliance with International Standards Organization (ISO) regulations, IVDR, FDA Quality System Regulation (QSR), and Twist corporate requirements.
- Supports administration of Management Review process such as gathering and establishing Quality Management System requirements and metrics.
- Responsible for problem solving and customer complaint investigations, nonconformities, and planned deviations.
- Provides project management leadership to various Quality-driven initiatives and represents Quality as-needed for representation on new product introduction and continuous improvement initiatives.
- Actively participate in customer/regulatory authority audit preparation efforts by supporting planning, gap analysis, and mitigation implementation activities required to comply with new regulation and standards.
- Assists and/or consults in the development of systems, procedures, and reports to improve all aspects of the quality assurance processes.
- Support Change Management, Inspection (product release) and CAPA Management
- Lead Risk Assessment for New Product Development and maintain risk management files
- Proven ability to work creatively and analytically in problem-solving and process-oriented environment.
- Proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives.
- Effectively influences and trains employees (as required).
- Maintains strong communication network with peers.
- Demonstrated effective knowledge and use of various computer systems.
- Additional responsibilities as assigned
- Ability to travel 10%
- Bachelor's degree in Life Sciences, Engineering or related field, or equivalent combination of education and work-related experience.
- 8+ years related experience in relevant medical diagnostic/device industry, including 3+ years of direct quality systems experience. Experience focused on quality systems and/or regulatory affairs/compliance.
- ASQ Certified Quality Engineer (CQE), Biomedical Auditor (CBA) and/or Six Sigma Green Belt a plus.
- Familiarity with regulatory requirements for IVD Products, ISO 9001, ISO 13485, 21CFR820, MDD, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
- Knowledge of ISO 14971 a plus.
- Proven interactions with all Quality Management and other departments.
- Familiarity with Confluence and JIRA applications desired.
- Strong written and verbal communication skills.
- Exposure to regulatory agency inspections (e.g., FDA, certification/notified bodies, etc.) and customer audits.
- Proven ability to work cross-functionally to achieve business outcomes.
About Twist Bioscience
At Twist Bioscience, we work in service of customers who are changing the world for the better. In fields such as medicine, agriculture, industrial chemicals and data storage, by using our synthetic DNA tools, our customers are developing ways to better lives and improve the sustainability of the planet.
Twist Bioscience Corporation is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.