Medidata Sdn. Bhd. Hiring! Full Time QA-QC Executive in Selangor, Earn up to MYR 2,500 - Ricebowl

Job Responsibilities:

· 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 the Company.

· Ensures ongoing compliance and up-to-date with quality standards and industry regulatory requirements.

· Performs random testing and inspection for incoming stocks and 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.

· Developing the yearly Training Needs Analysis and yearly Training Calendar by assisting superior in identifying and planning necessary trainings for the personnel involved in the supply chain activities/operations.

· Carries out other tasks or projects being assigned by the Management from time to time.

Job Requirement:

· Preferably a Bachelor’s Degree in Business, 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.

· Willing to learn, hardworking, and able to work under pressure.

Job Types: Full-time, Contract
Contract length: 12 months

Pay: From RM2,500.00 per month

Benefits:

• Health insurance
• Maternity leave
• Parental leave

Ability to commute/relocate:

• Kuala Selangor: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

• Expected salary ?
• Do you have experience as QA QC Executive?

Work Location: In person