Quality Assurance Lead – Medical Devices Compliance

Dexcom; Seberang Perai; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading medical technology company in Penang is seeking a Quality Assurance Manager to oversee daily operations and ensure compliance with industry standards. The role requires at least 3 years of experience in the medical device or pharmaceutical fields and a strong understanding of Quality Management Systems. You will monitor product quality, manage audits, and lead improvement initiatives while collaborating across teams. This role offers comprehensive benefits and growth opportunities within an innovative organization.

Benefits

Comprehensive benefits program

Career development programs

Global growth opportunities

Qualifications

• 3+ years of experience in medical device or pharmaceutical quality assurance.
• Understanding of regulatory standards (FDA, EU MDR).
• Experience conducting audits and ensuring compliance.

Responsibilities

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

Skills

Quality Management Systems (QMS)

Microsoft Office tools

Effective communication

Problem-solving

Adaptability in fast-paced environments

Tools

ERP systems

SAP

Job description

A leading medical technology company in Penang is seeking a Quality Assurance Manager to oversee daily operations and ensure compliance with industry standards. The role requires at least 3 years of experience in the medical device or pharmaceutical fields and a strong understanding of Quality Management Systems. You will monitor product quality, manage audits, and lead improvement initiatives while collaborating across teams. This role offers comprehensive benefits and growth opportunities within an innovative organization.