Quality Engineer

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The Quality Engineer is responsible for providing ongoing product quality engineering support throughout the product life cycle for multiple product platforms. The individual is responsible for ensuring compliance to 21 CFR 820, ISO 13485, EU IVDR, and other applicable international/local regulatory requirements.

• Conduct comprehensive reviews of batch records to ensure compliance with cGMPs and company procedures.
• Identify and investigate potential discrepancies or anomalies in batch records.
• Perform statistical analyses on batch data to assess product quality and identify trends.
• Prepare and maintain statistical reports to document findings and support quality decision‑making.
• Contribute to the development and implementation of quality control procedures.
• Participate in product release activities, including reviewing release documentation and providing quality assurance sign‑off.
• Stay up‑to‑date on the latest cGMP regulations and quality engineering practices.
• Provide quality support to quality control, field application scientists, and customer support.
• Provide support to design and development, engineering, and manufacturing for validation planning and transfer activities.
• Collaborate with Quality Management to support change control activities (e.g., engineering, process, raw materials, deviation management, and document change management).
• Ensure adequacy of complaint, non‑conformance, and CAPA records, investigations, and corrective/preventive actions.
• Represent QA and QC on the incident management committee in efficiently processing customer incidents and identifying trends to improve product quality.
• Provide quality support in the assessment and qualification of new supplier materials such as component specifications and inspection standards.
• Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change requests.
• Provide quality consultation to end users and process owners regarding data collection, analysis, and creation of validation reports.
• Become familiar with the applicable technology to participate in technical discussions and risk‑based decision making.
• Review verification and validation reports and identify gaps for compliance with internal quality requirements.
• Coordinate issue resolution using a risk‑based approach.
• Identify areas and opportunities to improve quality system processes and product issues.
• Ensure product development and validation programs meet internal quality standards.
• Trend, analyze, and report on quality data to improve product and processes.
• Provide management with status updates on assigned responsibilities and goals.
• Escalate issues in a timely fashion.
• Own and/or coordinate CAPAs, complaints, and NCRs specific to product quality issues.
• Effectively influence and train employees as required.
• Maintain a strong communication network with peers.
• Demonstrate effective knowledge of various computer systems.
• Additional responsibilities as assigned.
• Ability to travel 10%.
• Follow regulatory and ISO 13485 requirements.

• Bachelor’s degree in a scientific or engineering discipline and a minimum of 3 years of work experience in a quality engineering role; or equivalent experience.
• Familiarity with regulatory requirements for IVD products, ISO 13485, 21 CFR 820, IVDR, and experience in medical device or biotech manufacturing with a thorough knowledge of cGMP.
• Experience in pharmaceutical, NGS, and/or molecular diagnostics is a plus.
• Highly organized, with the ability to prioritize own tasks and work effectively virtually in conducting internal and external business.
• Strong interpersonal skills.
• Excellent oral and written communication skills, including the ability to articulate clear messages from complex data and information.
• Ability to work across functions throughout a global organization at all levels.

Mid‑Senior level

Full‑time

Quality Assurance

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