The Quality Assurance Specialist is a key member of the Quality Assurance Organization and reports to the Director of Quality Assurance. The role is dedicated to Customer Satisfaction through focused supplier management processes and product investigations, proactive identification of customer trends, and proper escalation of technical and customer issues. The role also focuses on supporting Internal Audits.
- Complies with departmental procedures and policies and appropriate Quality policies.
- Recognizes ISO requirements and are able to ensure we are in compliance.
- Review Supplier Issues, case and complaints according to established procedures to ensure compliance.
- Perform Supplier Evaluation of new and existing suppliers in order to meet ISO requirements for Supplier Management.
- Create and report on key metrics regarding Supplier Issue Ticket closure and customer complaints.
- Responsible for problem solving and escalated Supplier Issue management.
- Arrange conference calls and site visits for critical suppliers.
- Assists and/or consults in the development of systems, procedures, and reports to improve all aspects of the Supplier Quality processes.
- Assists in scheduling Internal Audits and managing the Internal Audit Schedule.
- Coordinates and participates in Internal Audits in addition to Supplier Audits
- Effectively influences and trains employees (as required).
- Maintains strong communication network with peers.
- Demonstrated leadership, motivational and organizational skills with a proven track record of accomplishments in cross-functional projects/teams/programs
- Demonstrated effective knowledge and use of various computer systems.
- Additional responsibilities as assigned
- Ability to travel 10%
- Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience.
- Minimum 2 years of Supplier Quality Assurance.
- Experience with performing Internal Audits (1 year minimum).
- Experience working and/or supporting production/laboratories 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.
- Proven interactions with all Quality Management and other departments.
- Certified Supplier Quality Professional (CSQP) or Certified Quality Audit (CQA) preferred.
- 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.).
- Proven ability to work cross-functionally to achieve business outcomes.
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.
San Francisco applicants: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.