QA/RA Specialist/ Quality System Engineer

o Serve as the Management Representative for SingPath Pte Ltd to drive, monitor and report on the adequacy, effectiveness, and continuing suitability of the company’s quality management system (QMS) in accordance with ISO 13485:2016, established policies/procedures, and applicable regulatory requirements.

o Promote awareness of applicable medical device regulations and Standards, and industry guidance documents.

o Manage documents and records control process including external origin documents.

o Evaluate, monitor, and re-evaluate suppliers. Maintain the Approved Supplier List (ASL).

o Manage the internal audit program to ensure timely execution in accordance with published schedule.

Manage the calibration program to ensure all monitoring and measuring equipment are inducted, calibrated, reviewed, and monitored in a timely manner.

o Bachelor’s degree in engineering (e.g., Mechanical, Chemical, Biomedical) or scientific discipline (e.g., Chemistry, Microbiology).

o Certified ISO 13485 Lead Auditor is preferred.

o Demonstrated successes in learning and applying new skills effectively.

o Strong interpersonal communication and analytical skills.

o Bilingual in English and Mandarin.

o Ability to work independently and in cross-functional teams.

o Prior work experience in quality management systems for medical devices is highly preferred.