Quality Assurance Lead – Medical Devices (Penang)

Dexcom Deutschland GmbH; Simpang Empat; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading health technology firm is seeking a Quality Support 2 in Penang, Malaysia. In this role, you will manage daily operations of the Quality Assurance team, ensure product quality compliance, and collaborate with cross-functional teams. Ideal candidates will have at least 3 years of experience in the medical device or pharmaceutical industry, a solid understanding of Quality Management Systems, and proficiency in Microsoft Office and ERP tools. You will also lead continuous improvement initiatives within the organization.

Benefits

Comprehensive benefits program

Growth opportunities on a global scale

Access to career development programs

Qualifications

• Minimum of 3 years experience in medical device or regulated industry.
• Understanding of Quality Management Systems for compliance.
• Experience with global regulatory standards like FDA and EU MDR.

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.
• Review and approve quality documentation and reports.
• Collaborate to resolve quality issues for new products.
• Train team members on quality procedures.
• Ensure compliance with ISO standards.
• Report quality metrics and recommend improvements.

Skills

Quality Management Systems (QMS)

Microsoft Office tools

Effective Communication

Problem-solving

Adaptability

Tools

ERP systems

SAP

Job description

A leading health technology firm is seeking a Quality Support 2 in Penang, Malaysia. In this role, you will manage daily operations of the Quality Assurance team, ensure product quality compliance, and collaborate with cross-functional teams. Ideal candidates will have at least 3 years of experience in the medical device or pharmaceutical industry, a solid understanding of Quality Management Systems, and proficiency in Microsoft Office and ERP tools. You will also lead continuous improvement initiatives within the organization.