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ProductMarketing and ServiceInternational business：
info@chinalikangyuan.com
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Marketing and ServiceInternational business：
info@chinalikangyuan.com
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Marketing and ServiceInternational business：
info@chinalikangyuan.com
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Contact UsMarketing and ServiceInternational business：
info@chinalikangyuan.com
Talent Recruitment
Make room for your dreams, and unlock limitless possibilities for the future.
Likangyuan Medical Devices
Committed to becoming a trusted global supplier of medical consumables, we safeguard health with meticulous craftsmanship and build a brighter future through unwavering responsibility.
QA Quality Control Engineer
Apr 28,2026
Job Requirements
Job Requirements
QA Quality Control Engineer
Campus Recruitment
Social Recruitment
No limit
山东省青岛市黄岛区
Full-time
Undergraduate
1–3 years
4000-6000
Job Responsibilities
1. Quality Management System Administration: Responsible for establishing, maintaining, and continuously improving the company’s ISO 13485, Medical Device GMP, FDA QMSR, and other quality management systems. This includes organizing the development, revision, training, and controlled management of system documentation; planning and conducting internal audits and management reviews; and tracking, rectifying, and verifying nonconformities.
2. Regulatory and Compliance Management: Monitor updates to domestic NMPA regulations and international medical device regulations and standards (such as MDR and FDA) to ensure product compliance. Participate in the preparation of registration, modification, and filing documentation, as well as compliance reviews. Oversee that manufacturing, testing, warehousing, procurement, and other operational processes comply with regulatory requirements and company quality management system standards.
3. Quality Control in the Manufacturing Process: Participate in the investigation, analysis, and resolution of manufacturing deviations, nonconforming products, and customer complaints, as well as in the development of CAPA measures. Oversee the review of batch production records and batch inspection records to ensure that they are accurate, complete, and traceable.
4. Product Release and Traceability Management: Conduct final review and approval of finished-product release, with definitive confirmation of batch record completeness, test results, and deviation handling. Assume responsibility for product labeling and traceability management to ensure end-to-end traceability of batch numbers, serial numbers, sterilization information, and other relevant data. Participate in product sample retention management and stability studies.
5. Adverse Event and Risk Management: Collect and report medical device adverse events, and conduct vigilance and recall activities in accordance with regulatory requirements. Participate in product FMEA risk analysis, risk control, and reevaluation. Handle customer complaints and returns to establish a closed-loop management system.
6. Training and Continuous Improvement: Organize training on quality, regulatory compliance, and management systems to enhance quality awareness across the organization. Promote the collection and analysis of quality data to drive continuous improvement of quality objectives.
Job Qualifications:
1. Bachelor’s degree or higher; candidates with majors in biomedical engineering, pharmacy, laboratory science, mechanical engineering, materials science, or related fields are preferred.
2. Familiar with the requirements of Medical Device GMP, ISO 13485, and QMSR quality management systems. Understand the regulatory requirements for medical device registration, manufacturing, inspection, adverse event reporting, and product recalls. Proficient in medical device manufacturing processes, batch records, deviation management, CAPA, and change control.
3. At least one year of experience in quality management systems within the medical device industry; prior experience with sterile medical devices is preferred.
Salary: 4,000–6,000
Contact: Manager Cui, Tel: 18562625393; Ms. Zhao, Tel: 13969751970; Office Phone: 89052777
