Job Description

Qualification and Experience

- Minimum Bachelor's Degree in Science / Chemical Engineering / Mechanical Engineering / Chemistry or equivalent.

- Knowledge and experience in medical device regulations, validation, audit, risk management, IOS 9001 and ISO 13485 quality management systems, cGMP and FDA in a regulated environment.

- Minimum 3-5 years working experience in related field.

Job description :

- Audit Planning, Preparation & Arrangement : ensure audit plan/ program is established appropriately inclusive audit schedule and defined area audit in a reasonable timeline.

- Audit execution - ensure the audit plan/programs implemented effectively.

- The execution of the audit shall cover system audit, process audit product audit to determine the compliance, its implementation, effectiveness of controls and accuracy of management systems and operations in compliance with ISO 13485, ISO 9001, cGMP, FDA, MDR guidelines and company established procedures.

- Audit reporting & status - to prepare and distribute audit report with audit findings for every section/ function audited.

- Record and issue any Non-Conformance Report (NCR) related to non-conformance matters.

Job Types: Full-time, Permanent

Pay: From RM3,500.00 per month

Work Location: In person