Job Description

Company Overview:

Our client is a high-tech biomedical company specializing in designing, developing, and manufacturing medical devices (e.g. artificial blood vessels, grafts, etc.) for both domestic and international markets. The facility includes clean rooms, QC & R&D labs, and operates under regulatory & quality standards such as ISO 13485, CE / MDD, and has Medical Device Single Audit Program (MDSAP) certification.

Position Summary:

The QC Officer is responsible for ensuring that all products, materials, and processes meet defined quality standards and regulatory requirements. They will perform inspections, testing, documentation, and coordination with production / R&D teams to uphold product integrity and compliance. This role requires attention to detail, understanding of medical device regulations, and ability to work in clean room and laboratory settings.

• Carry out incoming raw material inspections and verify certificates of analysis / supplier documentation.
• Conduct in-process inspections during manufacturing to ensure process conformity (dimensions, visual, mechanical, chemical, etc.).
• Perform final product inspections including physical, functional, and aesthetic checks before release.
• Carry out testing in the QC lab, which may include but not limited to sterility, biocompatibility, mechanical strength, leak tests, or others as required by product specifications.
• Ensure all measurement and test equipment are calibrated and maintained; report out-of-tolerance or malfunctioning equipment.
• Maintain clean room protocols: monitor cleanliness, gowning, environmental parameters (temperature, humidity, particulate count) as required.
• Document all QC activities accurately — inspection reports, nonconformance reports (NCR), test results, deviation reports.
• Work closely with R&D / Production teams to investigate defects, non-conformities, implement corrective and preventive actions (CAPA).
• Assist in audits (internal, external, regulatory) and ensure compliance with ISO 13485, MDSAP, CE / MDD, Medical Device Authority (MDA) or equivalent regulations.
• Participate in continuous improvement initiatives: process improvements, quality enhancements, reduction of defects.

Job Requirements

• Degree in Biomedical Engineering, Biotechnology, Mechanical Engineering, or related technical / life sciences field.
• Minimum 2-3 years experience in quality control / quality assurance in medical devices or regulated manufacturing. Experience in testing, clean room work, or medical implantable product testing is a plus.
• Good understanding of regulatory requirements: ISO 13485, MDSAP, CE / MDD, etc.
• Knowledge of QC tools & techniques: statistical process control (SPC), root cause analysis, CAPA.
• Competency in using laboratory / inspection equipment (microscopes, calipers, mechanical testers, etc.).
• Well versed in documentation and record keeping: SOPs, Batch records, NCRs, test reports.
• Attention to detail, high level of accuracy, good analytical skills.
• Ability to interpret technical drawings, specifications, and standards.
• Able to work under clean room conditions; willing to comply with hygiene, gowning, environmental controls.
• Good communication skills (verbal and written), team-oriented, proactive attitude.
• Familiarity with audits and regulatory inspections is advantageous.

Skills