QA / Qc Specialist

3 days ago

Kuala Selangor, Malaysia MEDIDATA SDN BHD Full time

**JOB DESCRIPTION**
- Ensures the compliance to ISO 13485, ISO 9001, Good Distribution Practice for Medical Device (GDPMD) standards and any other relevant regulatory standards at all times.
- In charge of prepare, review, implement, and maintain the ISO 13485 and ISO 9001 quality management system, as well as the GDPMD regulatory compliance system.
- Part of Risk Management Team & Post Marketing Surveillance Team.
- Evaluates audit findings and implements appropriate corrective actions. Investigates, plans and monitors the corrective and preventive action plan.
- Handles all internal audit and external audits, customer and regulatory audit needed by Company.
- Ensures ongoing compliance and up-to-date with quality standards and industry regulatory requirements.
- Performs random testing and inspection for incoming stocksand finished products. Collects, compiles, and analyses statistical quality data.
- Liaises with the external parties including government body and certification body on matters relating to the Malaysian medical device regulatory requirements.
- Assists superior to ensures validity and on-time renewal of ISO certifications, GDPMD certifications and CE marking with the relevant Authorities.
- Prepares reports to communicate outcomes of quality activities. Investigates customer complaints and internal non-conformances of materials and finished products.
- Assists superior in identifying and planning necessary trainings for the personnel involved in the supply chain activities/operations and period the training to satisfy these needs.
- Carries out other tasks or projects being assigned by the Management from time to time.

**JOB REQUIREMENT**
- Preferably a Bachelor’s Degree in Engineering, Biomedical Science, Medical Science or any other related studies.
- Knowledgeable in ISO 13485, ISO 9001 and GDPMD.
- Working experience in QA QC is an added advantage.
- Good command in English and Bahasa Malaysia both in written and spoken.
- Positive working attitude and result-oriented person.
- Team player and also able to work independently with minimum supervision.
- Healthy and self-motivated person.

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