QA Engineer at Aceve collaborating with product development teams to design and execute effective test strategies for high - quality software releases. Enhancing quality with test automation and proactive involvement.
About the role
- Quality Assurance Engineer ensuring compliance with ISO 13485 in medical device production. Leading failure analysis, overseeing testing, and managing quality improvement initiatives.
Responsibilities
- Review Device History Records (DHR) for medical device products in the Post LQ laboratory, ensuring all production, inspection, and release records are complete and compliant with ISO 13485 and company quality system requirements.
- Lead product Failure Analysis (FA): collect failed samples, develop analysis plans, conduct testing and data analysis, and generate FA reports to drive root cause closure and continuous improvement.
- Oversee batch product functional testing, visual inspection, and performance verification; promptly identify and address anomalies, and drive implementation of Corrective and Preventive Actions (CAPA).
- Support laboratory equipment management, including calibration, maintenance, and verification, ensuring accuracy and reliability of test data.
- Participate in customer complaint handling, returns, and nonconformance management, including data collection, root cause analysis, and corrective action planning.
- Engage in supplier audits, incoming material and finished product inspections, ensuring supply chain quality stability.
- Collect and analyze quality data, regularly generate quality reports, and support laboratory performance improvement.
- Organize or participate in quality training for staff to enhance team quality awareness and operational skills.
- Communicate effectively with cross-functional teams and global stakeholders in both Chinese and English.
Requirements
- Bachelor’s degree or above in Mechanical Engineering, Materials Science, Biomedical Engineering, Quality Management, or related fields.
- Minimum 2 years of quality engineering or management experience in the medical device or related industry, with solid knowledge of ISO 13485 and GMP regulations.
- Proficient in DHR review processes and failure analysis methodologies, with strong problem-solving skills.
- Skilled in quality tools (FMEA, SPC, 8D, QC tools) and capable of independently preparing analysis reports.
- Familiar with common measurement instruments and laboratory operations.
- Strong communication and teamwork skills; able to work under pressure.
- Advanced data analysis skills; proficient in Excel, Minitab, or similar tools.
- Experience with medical device registration, quality system audits, or supplier management is a plus.
- Continuous improvement mindset and ability to proactively drive quality projects.
- Excellent English reading, writing, and speaking skills are mandatory.
- Ability to read and draft technical documents and communicate with global teams in English is required.
Benefits
- Health insurance
- Flexible working hours
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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