Medical Device QA Engineer - CAPA & Process Improvement

Agensi Pekerjaan Minde Group Sdn Bhd; Johor Bahru; On-site; MYR 67,000 - 112,000; Full time

Job summary

Agensi Pekerjaan Minde Group Sdn Bhd seeks a Quality Engineer for Medical Device manufacturing in Malaysia. The role ensures compliance with internal quality systems, regulatory requirements, and customer expectations through oversight of manufacturing activities.

The incumbent will support validation, CAPA, and continuous improvement initiatives, review quality documents, and participate in audits and PMS activities to maintain product quality and compliance.

Qualifications

• Bachelor's degree in Engineering (Manufacturing, Materials, Biomedical, or a related discipline)
• Strong verbal and written communication skills with good proficiency in English
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook, and related tools)

Responsibilities

• Provide quality oversight to ensure manufacturing activities comply with internal quality systems, applicable regulatory requirements, and customer expectations.
• Support process and equipment validation activities, including review of validation protocols, reports, controls, and data integrity.
• Lead or support investigation of quality issues using structured root cause analysis (RCA) methodologies and drive effective corrective and preventive actions (CAPA).
• Prepare, review, and approve quality documentation such as control plans, inspection procedures, validation documents, and related records.
• Collaborate with manufacturing teams to support continuous improvement initiatives while ensuring product quality and compliance are maintained.
• Support supplier and component quality activities, including evaluation of supplier performance and quality-related issues, where applicable.
• Support post-market surveillance (PMS) activities by investigating complaints, identifying trends, and translating findings into preventive and improvement actions.
• Support internal and external audits to ensure effective implementation of quality systems at the manufacturing site.
• Communicate quality requirements clearly to manufacturing personnel and elevate quality risks or non-conformances as required.
• Participate in Lean, Kaizen, and other quality or process improvement initiatives with cross-functional teams.

Skills

Communication skills

English proficiency

MS Office

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

Job description

Agensi Pekerjaan Minde Group Sdn Bhd seeks a Quality Engineer for Medical Device manufacturing in Malaysia. The role ensures compliance with internal quality systems, regulatory requirements, and customer expectations through oversight of manufacturing activities.

The incumbent will support validation, CAPA, and continuous improvement initiatives, review quality documents, and participate in audits and PMS activities to maintain product quality and compliance.