The Staff Quality Engineer – Regulatory Compliance is responsible for establishing and maintaining effective structures to ensure consistent implementation of quality systems at Twist Bioscience. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidances and standards.
What You’ll Be Doing
- Identify internal requirements and external laws, regulations, guidance standards applicable to manufacturing of In-Vitro Diagnostics and Antibodies
- Collaborate with cross-functional teams to address QMS noncompliance and develop remediation plans
- Lead efforts to address remediation deliverables (e.g procedures, risk management, technical documentation, work instructions, Safety Data Sheets)
- QA representative on Core Teams for FDA regulated products
- Review Production Issues (PI), non-conformances, and deviations according to established procedures to ensure compliance.
- Manage CAPA program, which includes the management of robust CAPA Training program.
- Participate cross functionally and across business units (i.e BioPharma, IVD, RUO) to standardize business quality system policies and procedures
- Demonstrated effective knowledge and use of various computer systems.
What You’ll Bring to the Team
- 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.
- 9+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience
- Knowledge of good manufacturing practices required
- Solid understanding of EU IVD and USA IVD Regulations
- Solid understanding of ISO 14971, ISO 13485, 21 CFR 820, 21 CFR 210/211, ICH
- Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required
- Experience with document management systems required
Preferred Qualifications
- Experience with Atlassian Confluence and JIRA
- Comprehensive knowledge and application business concepts, procedures and practices
- Knowledge of Product Lifecycle Management
- Ability to work independently and lead and mentor others required
- Demonstrated strong attention to detail and “do it right the first time” attitude required
- Good judgment and decision-making skills are required (knows how to make trade-off decisions while balancing compliance and business impact)
- Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required
- Experience with Design Quality responsibilities preferred
- Experience performing Internal and External QMS Audits
- ASQ Quality Certification
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.
