Sr Quality Assurance Specialist

Sr. Quality Engineer - Supplier Quality (Onsite)

The Quality Engineer will provide expertise and support compliance of Supplier Controls with applicable Regulations and Standards (ISO 13485:2016, IVDR, FDA 21 CFR 820, etc.). They will lead Supplier Quality Team Meetings, Internal CAPAs (related to supplier controls), Supplier Incidents resolutions, SCARs, and Supplier Audits. They will support the Internal Audit Program. They will Interact with individuals at multiple levels within all functional departments, including Quality Assurance Engineering, Software Quality Assurance, R&D, and Marketing.

What You'll Be Doing

• Own Supplier Quality processes including Supplier Controls, Global Supplier Selection, Evaluation and Re-Evaluations, SCAR Processes and Supplier Monitoring as a Corporate Business Process Owner.

• Run weekly Supplier Quality Team meetings (High Level and Supplier Issues) with cross functional stakeholders presenting the status of Supplier Quality health with metrics on Audits, SCARs, Supplier nonconformances and ASL.

• Collaborate with Regulatory Affairs/Quality Systems team and Periodically analyze and review Supplier Controls process to stay in compliance with latest applicable Regulations and Standards.

• Lead internal CAPAs related to Supplier Controls.

• Lead high visibility SCARs and Key Supplier Audits (Evaluations and Re-Evaluations) as a Lead Auditor.

• Support Internal and External Audits (FDA, EUIVDR, ISO, Customer, etc.) representing Supplier Quality in Audits Front rooms.

• Lead Projects as a Project Manager to improve Supplier Controls Processes to improve efficiency and compliance.

• Be a technical custodian of Supplier Data Monitoring and Analysis. Analyze and prepare data for Supplier Data Monitoring and Analysis. Analyze and prepare data for Supplier Quality Team meetings and monitor data for accuracy.

• Review and Approve Product SCARs and be the lead for SCAR Review Boards

• Support Purchasing (category buyers/managers) on Quality Management System elements of Supplier Agreement negotiations with Suppliers.

• Assist in scheduling Internal Audits and managing the Internal Audit Schedule.

• Coordinate and participate in Internal Audits in addition to Supplier Audits.

• Ensure the Quality Systems group is appropriately staffed to ensure timely completion of responsibilities.

• May lead or manage team members.

• Follow regulatory and ISO 13485 requirements

What You'll Bring to the Team

• Bachelor's in Chemistry, Biochemistry, Molecular Biology, Biomedical Engineering, Drug Development & Product Management, or a related scientific or engineering discipline.

• 5 years of QA experience working in drug or medical-device regulated industry

• Knowledge of supplier qualification activities.

• Knowledge of good manufacturing processes.

• ISO 13485:2016 Lead Auditor Certification

• Experience leading and mentoring team members.

• Experience making trade-off decisions while balancing compliance and business impact.

• Experience working in cross functional teams.

• Experience implementing practical Quality System and Compliance solutions.

About Twist Bioscience

Twist Bioscience synthesizes genes from scratch, known as "writing" DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.

At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.

Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.