Quality Engineer

Twist Bioscience

. Provide ongoing product quality engineering support throughout the product life cycle for multiple product platforms.

Posted 9/30/2026full-timeRemote • ChinaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality engineering with a strong focus on regulatory compliance, including 21 CFR 820 and ISO 13485. Proficient in statistical analysis, quality control procedures, and cross-functional collaboration to enhance product quality and compliance.

Highest-signal resume keywords

Quality EngineeringRegulatory ComplianceStatistical AnalysisQuality Control ProceduresInterpersonal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisQuality Control ProceduresRegulatory ComplianceDeviation ManagementCAPA ActivitiesRisk ManagementDocument Change ManagementBatch Record ReviewVerification and ValidationSupplier Qualification

Soft Skills

Strong Interpersonal SkillsExcellent Oral CommunicationExcellent Written CommunicationOrganizational SkillsAbility to Prioritize Tasks

Industry Keywords

21 CFR 820ISO 13485EU IVDRCGMPIVD ProductsPharmaceuticalNGSMolecular DiagnosticsMedical Device ManufacturingBiotech Manufacturing

About the role

Key responsibilities & impact

Provide ongoing product quality engineering support throughout the product life cycle for multiple product platforms.
Ensure compliance with 21 CFR 820, ISO 13485, EU IVDR, cGMPs, and other applicable regulatory requirements.
Review batch records and investigate discrepancies or anomalies.
Perform statistical analyses on batch data and prepare statistical reports.
Develop and implement quality control procedures.
Participate in product release activities and provide quality assurance sign-off.
Support quality control, field application scientists, and customer support.
Support validation planning, transfer activities, design and development, engineering, and manufacturing.
Support change controls, deviation management, document change management, complaints, non-conformances, and CAPA activities.
Represent QA and QC on the incident management committee and identify quality trends.
Assess and qualify new supplier materials.
Drive product risk management and ensure completeness of design history files, validation packages, and change requests.
Review verification and validation reports and identify compliance gaps.
Coordinate issue resolution using a risk-based approach.
Trend, analyze, and report quality data to improve products and processes.
Provide management status updates and escalate issues in a timely manner.
Train employees as required and maintain communication with peers.
Travel 10%.

Requirements

What you’ll need

Bachelor’s degree in a scientific or engineering discipline, plus a minimum 3 years of work experience in quality engineering role; or equivalent work required.
Familiarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, IVDR, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
Experience in Pharmaceutical, NGS, and/or Molecular Diagnostics a plus.
Highly organized, with ability to prioritize own tasks and ability to 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/information.
Ability to work across functions throughout a global organization at all levels.
Ability to travel 10%.
Follow regulatory and ISO 13485 requirements.

Benefits

Comp & perks

Remote work schedule
Ability to work effectively virtually
Global organization collaboration opportunities