Quality Engineer

Job not on LinkedIn

🕒 September 30

🇨🇳 China – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 46 days.
• Jobs at this company usually fill in 51 days.
• No salary listed.

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Twist Bioscience

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2013

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

Twist Bioscience is a biotechnology company that develops a proprietary semiconductor-based synthetic DNA manufacturing process. This innovative platform enables miniaturization of chemistry necessary for DNA synthesis, providing significant time and cost savings for customers. Twist offers a range of DNA-based products including gene synthesis, variant libraries, and next-generation sequencing (NGS) solutions. The company supports research across areas such as cancer research, infectious disease, and drug discovery, leveraging its capabilities to drive groundbreaking biological innovations. With a robust suite of tools and services, Twist Bioscience is at the forefront of advancing research in genomics, antibody discovery, and synthetic biology.

📋 Description

• 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

• 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

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

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