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Trustworthy

<p><strong>Company Overview:</strong></p>
<p>Our client is a<strong> </strong>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 &amp; R&amp;D labs, and operates under regulatory &amp; quality standards such as ISO 13485, CE / MDD, and has Medical Device Single Audit Program (MDSAP) certification.</p>
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<p><strong>Position Summary:</strong></p>
<p>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&amp;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.</p>
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<ul>
<li>Carry out incoming raw material inspections and verify certificates of analysis / supplier documentation.</li>
<li>Conduct in-process inspections during manufacturing to ensure process conformity (dimensions, visual, mechanical, chemical, etc.).</li>
<li>Perform final product inspections including physical, functional, and aesthetic checks before release.</li>
<li>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.</li>
<li>Ensure all measurement and test equipment are calibrated and maintained; report out-of-tolerance or malfunctioning equipment.</li>
<li>Maintain clean room protocols: monitor cleanliness, gowning, environmental parameters (temperature, humidity, particulate count) as required.</li>
<li>Document all QC activities accurately — inspection reports, nonconformance reports (NCR), test results, deviation reports.</li>
<li>Work closely with R&amp;D / Production teams to investigate defects, non-conformities, implement corrective and preventive actions (CAPA).</li>
<li>Assist in audits (internal, external, regulatory) and ensure compliance with ISO 13485, MDSAP, CE / MDD, Medical Device Authority (MDA) or equivalent regulations.</li>
<li>Participate in continuous improvement initiatives: process improvements, quality enhancements, reduction of defects.</li>
</ul>


This job is about being a Quality Control Officer in a high-tech biomedical company that makes medical devices. You might like this job because you ensure products are safe and effective, working closely with teams to maintain high standards and improve processes.

Quality Control

Quality Improvement

Product Quality (QA/QC)

ISO 13485 Standard

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 and RandD labs, and operates under regulatory and 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 a...

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