Director, Quality Operations & Compliance

Insulet; Gelang Patah; On-site; MYR 350,000 - 650,000; Full time

Job summary

Insulet Malaysia (IMY) seeks a Director of Quality Operations to lead site quality systems and ensure full compliance with US FDA, ISO 13485, and applicable regulatory requirements. The role includes representing the site QMS, reporting to top management on effectiveness, and promoting regulatory awareness across the organization.

The candidate will manage QE/QC/QA teams, drive continuous improvement, and ensure products meet DMR requirements before release.

Qualifications

• Bachelor’s degree in Science, Engineering, or a related discipline is required.
• Minimum of 12 years of experience in Medical Device Quality Operations, including at least 10 years in a Quality Manager or equivalent leadership role.

Responsibilities

• Leads a team of QE, QC, and QA associates, ensuring strong performance and collaboration with key stakeholders.
• Establishes and promotes strategies to achieve quality objectives and regulatory compliance.
• Ensures CAPA, QMS audits, and environmental monitoring are effectively managed.

Skills

Leadership

Risk-based decisions

Communication

Global mindset

Quality systems knowledge

Education

Bachelor’s degree in Science/Engineering

Tools

Power BI

Excel

Word

Job description

Insulet Malaysia (IMY) seeks a Director of Quality Operations to lead site quality systems and ensure full compliance with US FDA, ISO 13485, and applicable regulatory requirements. The role includes representing the site QMS, reporting to top management on effectiveness, and promoting regulatory awareness across the organization.

The candidate will manage QE/QC/QA teams, drive continuous improvement, and ensure products meet DMR requirements before release.