QA Analyst, Medical Devices - Quality & Compliance

Ansell; Malacca City; On-site; MYR 72,000 - 108,000; Full time

Benefits offered by this job

Annual performance bonus

Inclusive workplace

Job summary

Ansell is seeking an Analyst, QA based in Ayer Keroh, Melaka. The role develops and maintains QA procedures to ensure compliance with medical device standards and drives improvements in manufacturing and testing.

Responsibilities include inspection planning, data analysis, and supporting audits and regulatory compliance, with collaboration across production and quality teams to sustain high product quality and safety.

Qualifications

• Degree in Science or related field with QA focus.
• Experience in medical device or regulated industry preferred.
• Familiarity with QSR/ISO 13485/ISO 9001 and regulatory requirements.

Responsibilities

• Develop, administer and maintain QA procedures to ensure compliance with medical device quality standards.
• Coordinate and perform quality inspections and release of products/materials.
• Lead continuous improvement and corrective action initiatives with cross-functional teams.
• Review documentation, test plans, and control plans for processes and products.
• Support internal and external audits and supplier quality activities.

Skills

Quality mindset

Communication skills

Decision making

Analytical thinking

Education

Science degree (Material, Polymers, Biomedical, Engineering, Chemistry or QMS)

Job description

Ansell is seeking an Analyst, QA based in Ayer Keroh, Melaka. The role develops and maintains QA procedures to ensure compliance with medical device standards and drives improvements in manufacturing and testing.

Responsibilities include inspection planning, data analysis, and supporting audits and regulatory compliance, with collaboration across production and quality teams to sustain high product quality and safety.