Quality Support

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

Assist with the day-to-day operations associated with Control of Nonconforming Materials. Assist management to ensure that products, procedures, and processes comply with applicable regulations and standards.

Where you come in:

You manage the daily operations of the Quality Assurance team to ensure adherence to company standards and regulatory requirements.

You monitor product quality and implement corrective actions to maintain compliance with specifications.

You lead root cause analysis and drive continuous improvement initiatives to enhance product reliability.

You review and approve quality documentation, reports, and audit findings for accuracy and completeness.

You collaborate with cross-functional teams to resolve quality issues and support new product introductions.

You train and mentor team members to strengthen technical skills and ensure consistent application of quality procedures.

You ensure compliance with ISO standards and customer requirements through regular audits and process evaluations.

You report key quality metrics to management and recommend strategies for improvement.

What makes you successful:

You have a minimum of 3 years of experience working in the medical device, pharmaceutical, or other regulated industry within the Quality Assurance department.

You understand Quality Management Systems (QMS) as applied to medical devices and can ensure compliance with regulatory standards.

Your proficiency includes Microsoft Office tools and ERP systems for documentation and reporting.

You communicate effectively and clearly across teams and stakeholders.

You work hands-on in a fast-paced environment and adapt quickly to changing priorities.

You can flex your schedule and work different shifts to support commercial production runs.

Your experience includes working with global regulatory standards (FDA, EU MDR) and supporting audits.

You have exposure to additional systems such as SAP or other advanced ERP platforms.

What you’ll get:

A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.

A full and comprehensive benefits program.

Growth opportunities on a global scale.

Access to career development through in-house learning programs and/or qualified tuition reimbursement.

An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.