QA EXECUTIVE (Medical Device Manufacturing/ Healthcare)

Job Description

• Lead in Drawing Requirement Form (DRF) Transfer Documentation (Inspection Standard)

Lead in Process Flow Record (PFR) Traceability and Reject Record

• Manage sample of product and Responsible in Updating Keep Sample Master List

Lead in updating QC Equipment List & QC Work Instruction (WI)

• Prepare Certificate of Analysis & Certificate of Origin as per Customer Requirement

Perform First Article Inspection (FAI) to new introduce product or any technical changes that related to product.

• Prepare Concession Acceptance for accepted defect criteria.

Prepare Return Material Authorization (RMA) & assist in follow up with supplier regarding defect item.

• Assists Quality Inspector for Incoming Quality Checking (IQC), In-Process Quality

Checking (IPQC) First Shot, Final Inspection, Out- Going Quality Checking (OQC)

• Assists in Weighing Balance Verification for Internal Calibration

Assists in Conducting Monthly Operator Assessment to ensure products and processes.

• comply with the relevant requirements of the Quality Management System.

Assist Quality Engineer with Corrective and Preventive Actions for any Non-Conformity.

• Able to communicate and write in English, Bahasa Malaysia & Mandarin.

Reports

• Internal audit

Responsible to ensure the SOP and documentation related to ISO 13485 and QMS System are maintained and up to date.

Job Types: Full-time, Permanent

Pay: RM1,

• 00 - RM3,800.00 per month
  
  Benefits:
• Flexible schedule

Free parking

• Maternity leave

Schedule:

• Monday to Friday

Supplemental pay types:

• Overtime pay

Performance bonus

Language:

* Mandarin, Malay and English (Required)