QA Analyst – Medical Devices Quality & Compliance

Ansell Limited; Malacca City; On-site; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive remuneration

Annual performance bonuses

Inclusive work environment

International exposure

Job summary

Ansell Limited in Melaka is seeking an Analyst, QA to develop, administer and maintain quality assurance procedures for medical device processes and products. You will analyze performance, implement improvements and ensure compliance with regulatory standards.

Role involves coordinating QA operations, participating in audits, and driving actions to release high-quality surgical products. Excellent collaboration across teams and ongoing process enhancements are expected.

Qualifications

• 2 to 5 years’ experience as a Quality Engineer in the medical device industry.
• Knowledge of FDA QSR, ISO 13485 and MDR is preferred.
• Strong analytical and problem-solving abilities

Responsibilities

• Develop and maintain QA procedures to ensure compliance with medical device standards.
• Manage QA operations and inspection activities for finished products.
• Coordinate quality audits and corrective actions.
• Support process improvements using SPC methods.

Skills

Quality engineering

Auditing

Statistical process control

Communication skills

Education

Science degree

Job description

Ansell Limited in Melaka is seeking an Analyst, QA to develop, administer and maintain quality assurance procedures for medical device processes and products. You will analyze performance, implement improvements and ensure compliance with regulatory standards.

Role involves coordinating QA operations, participating in audits, and driving actions to release high-quality surgical products. Excellent collaboration across teams and ongoing process enhancements are expected.