QA Quality Analyst - Medical Devices

Ansell Global Trading Center (Malaysia) Sdn Bhd; Ayer Keroh; On-site; MYR 60,000 - 88,000; Full time

Benefits offered by this job

Annual performance bonus

Competitive remuneration

Inclusive work environment

Global exposure

Job summary

Ansell Global Trading Center (Malaysia) Sdn Bhd is seeking an Analyst, QA based in Ayer Keroh, Melaka. The role focuses on developing, maintaining, and improving QA procedures to ensure compliance with medical device quality standards.

You will lead inspections, manage QA personnel, and drive continuous improvement across receiving, in-process, and final product testing. The ideal candidate has a science degree and 2–5 years’ QA engineering experience in the medical device sector, with strong

Qualifications

• Minimum 2–5 years’ experience as a Quality Engineer in the medical device industry or related sectors.
• Familiarity with FDA QSR, ISO 13485 and MDR regulatory requirements.

Responsibilities

• Understand and implement the company Quality Policy and related environmental, safety, and quality standards.
• Coordinate and supervise QA operations per documented procedures and work instructions.
• Prepare data, monitor trends, conduct investigations into finished product inspection results and failures.
• Ensure timely release of QA results and conformance to GMP and quality specifications.

Skills

Quality Assurance

Quality Engineering

Audit

Problem Solving

Documentation

Process Improvement

Training

Regulatory Awareness

Education

Science degree (Material/Polymers/Bio Medical/Engineering/Chemistry/Quality Mgmt)

Job description

Ansell Global Trading Center (Malaysia) Sdn Bhd is seeking an Analyst, QA based in Ayer Keroh, Melaka. The role focuses on developing, maintaining, and improving QA procedures to ensure compliance with medical device quality standards.

You will lead inspections, manage QA personnel, and drive continuous improvement across receiving, in-process, and final product testing. The ideal candidate has a science degree and 2–5 years’ QA engineering experience in the medical device sector, with strong