Quality Engineer

This is a fully remote position, open to applicants in China.

📋 Description

• Provide continuous product quality engineering support throughout the entire product life cycle for various product platforms.

• Ensure adherence to 21 CFR 820, ISO 13485, EU IVDR, cGMPs, and other relevant regulatory standards.

• Examine batch records and investigate any discrepancies or anomalies.

• Conduct statistical analyses on batch data and generate statistical reports.

• Develop and implement quality control protocols.

• Engage in product release activities and provide quality assurance sign-off.

• Assist quality control, field application scientists, and customer support teams.

• Aid in validation planning, transfer activities, design and development, engineering, and manufacturing processes.

• Support change control processes, deviation management, document change management, complaints, non-conformances, and CAPA activities.

• Represent QA and QC on the incident management committee and identify quality trends.

• Evaluate and qualify new supplier materials.

• Lead product risk management initiatives and ensure the completeness of design history files, validation packages, and change requests.

• Review verification and validation reports to identify compliance gaps.

• Coordinate issue resolution using a risk-based strategy.

• Trend, analyze, and report quality data to enhance products and processes.

• Provide management status updates and escalate issues promptly.

• Train employees as necessary and maintain communication with colleagues.

• Travel required: 10%.

⛳️ Requirements

• Bachelor’s degree in a scientific or engineering field, along with a minimum of 3 years of experience in a quality engineering role; or equivalent experience is required.

• Familiarity with regulatory standards for IVD products, ISO 13485, 21 CFR 820, IVDR, and relevant experience in medical device or biotech manufacturing, as well as a comprehensive understanding of cGMP.

• Experience in pharmaceuticals, NGS, and/or molecular diagnostics is advantageous.

• Highly organized, capable of prioritizing tasks effectively and working efficiently in a virtual environment for both internal and external business interactions.

• Strong interpersonal abilities.

• Exceptional oral and written communication skills, including proficiency in conveying clear messages from complex data/information.

• Ability to collaborate across functions within a global organization at all levels.

• Willingness to travel: 10%.

• Comply with regulatory standards and ISO 13485 requirements.

🏝️ Benefits

• Remote work schedule

• Capability to work effectively in a virtual setting

• Opportunities for collaboration within a global organization