Quality Assurance Lead - Regulated Medical Devices

Dexcom; Penang; On-site; MYR 100,000 - 150,000; Full time

Job summary

A medical technology leader is seeking a Quality Assurance professional in Penang, Malaysia. This role requires a minimum of 3 years in QA within the medical device or pharmaceutical industry, understanding of regulatory standards, and experience with QMS. Responsibilities include managing QA operations, ensuring product compliance, leading audits, and supporting new product introductions. Candidates must be adaptable to work in a dynamic environment. A comprehensive benefits program and growth opportunities are offered.

Benefits

Comprehensive benefits program

Growth opportunities

Career development programs

Qualifications

• Minimum of 3 years of experience in the medical device or pharmaceutical industry within Quality Assurance.
• Strong understanding of regulatory requirements and compliance.
• Ability to flex schedule to support production runs.

Responsibilities

• Manage daily operations of the Quality Assurance team.
• Monitor product quality and implement corrective actions.
• Lead root cause analysis and continuous improvement initiatives.

Skills

Experience in Quality Assurance

Quality Management Systems (QMS)

Microsoft Office Tools

Communication Skills

Hands-on Work Ethic

Adaptability

Tools

ERP Systems

SAP

Job description

A medical technology leader is seeking a Quality Assurance professional in Penang, Malaysia. This role requires a minimum of 3 years in QA within the medical device or pharmaceutical industry, understanding of regulatory standards, and experience with QMS. Responsibilities include managing QA operations, ensuring product compliance, leading audits, and supporting new product introductions. Candidates must be adaptable to work in a dynamic environment. A comprehensive benefits program and growth opportunities are offered.