Quality Engineer — Regulatory Compliance & Data Insight

Twist Bioscience Corporation; United States; On-site; USD 85,000 - 125,000; Full time

Job summary

Twist Bioscience Corporation is seeking a Quality Engineer to support product quality engineering across lifecycle for multiple platforms. You will ensure compliance with 21 CFR 820, ISO 13485, IVDR, and other regulatory requirements.

Responsibilities include batch record reviews, investigation of discrepancies, statistical analyses, and participation in product releases. You will collaborate across QA, QC, development, engineering, and manufacturing to strengthen validation and change-control

Qualifications

• Bachelor’s degree in science or engineering required.
• Experience with regulatory requirements (IVD/medical devices) a must.
• 3+ years in quality engineering or related field preferred.

Responsibilities

• Review batch records for cGMP and ISO compliance.
• Identify and investigate discrepancies or anomalies in batch records.
• Perform statistical analyses on batch data to identify trends.
• Prepare statistical reports to document findings and support decisions.
• Contribute to development and implementation of quality control procedures.
• Participate in product release activities with QA sign-off.
• Stay up-to-date on cGMP regulations and quality practices.
• Provide quality support to QC, scientists, and customer support.
• Collaborate with design, development, engineering, and manufacturing on validation planning and transfers.
• Support change controls, deviations, and document change management.

Skills

Quality engineering

Regulatory knowledge

Data analysis

Cross-functional collaboration

Documentation

Education

B.S. in science/engineering

Tools

LIMS

CAPA systems

Job description

Twist Bioscience Corporation is seeking a Quality Engineer to support product quality engineering across lifecycle for multiple platforms. You will ensure compliance with 21 CFR 820, ISO 13485, IVDR, and other regulatory requirements.

Responsibilities include batch record reviews, investigation of discrepancies, statistical analyses, and participation in product releases. You will collaborate across QA, QC, development, engineering, and manufacturing to strengthen validation and change-control