Manager, Quality Systems

Job Summary

Position Overview:

The Quality System Manager leads the Quality Management System (QMS) for the Insulet Malaysia manufacturing site and all its key processes.
Reporting to the Director, Quality Operations, the role oversees QMS governance, Change Review Board (CRB), document control, quality auditing, CAPA, quality KPIs and key process metrics, and regulatory compliance. The Quality System Manager works closely with local and global teams to maintain an effective and compliant QMS and drive continuous improvement.

Responsibilities:

 

• Quality Management System
  • Lead the implementation, maintenance, and continuous improvement of the QMS at the Malaysia site.
  • Ensure local quality system processes are aligned with global procedures and applicable regulatory requirements.
  • Monitor QMS effectiveness and partner with local and global teams to drive improvements and implement quality system initiatives across key processes.

• Change Order & Document Control
  • Oversee change order and document control activities, ensuring documents and changes are properly reviewed, approved, implemented, and maintained.
  • Assess quality system changes for compliance, implementation, and training impact.
  • Ensure timely implementation of quality system and document changes.

• Quality Auditing
  • Manage the site quality audit program, including internal quality system and process audits.
  • Support regulatory, certification, corporate, and customer audits and ensure findings are appropriately addressed.
  • Maintain site readiness for regulatory inspections and quality system audits by conducting period audits on key processes.

• CAPA Management
  • Oversee the site CAPA process, including investigation, root cause, action plans, effectiveness verification, and closure.
  • Monitor CAPA performance, aging, recurring issues, and effectiveness.
  • Drive timely resolution and escalation of significant quality system issues.

 

• Quality KPIs & Metrics
  • Establish and monitor quality system KPIs, metrics, and dashboards.
  • Monitor quality system trends, performance, and compliance risks and drive improvement with process owners.
  • Support quality management review and other management reporting activities.

• Regulatory Compliance
  • • Ensure the site QMS complies with applicable medical device regulations and standards, including ISO 13485, FDA Quality Management System requirements, MDSAP, EU MDR, and applicable Malaysia regulatory requirements.
    • Support regulatory inspections and certification audits.
    • Partner with Regulatory Affairs, Global Quality, and site teams to implement regulatory and quality system requirements and maintain inspection readiness.
  • Leadership & Collaboration
    • Lead and develop the Quality Systems team and promote a culture of quality, compliance, and continuous improvement.
    • Collaborate with Operations, Manufacturing, Engineering, Regulatory Affairs, Supplier Quality, and other functions.
    • Partner with Global Quality teams and communicate quality system performance, risks, and improvement priorities to key stakeholders.

Qualifications & Experience

• • Bachelor’s Degree in engineering, science, quality management, or related technical discipline.
  • Minimum 8 years of quality assurance or quality systems experience, preferably within the medical device industry.
  • Strong knowledge and practical experience with ISO 13485 and medical device quality management systems. MDSAP and EU MDR 2017/745 will be advantages.
  • Experience with CAPA, quality auditing, change control, document control, quality metrics, MSA, SPC and regulatory compliance.
  • Experience managing regulatory and certification audits.
  • Previous people management or team leadership experience.
  • Experience with electronic quality management systems and working with local and global teams is preferred.

Skills & Competencies:

• Strong quality systems, regulatory, root cause analysis, and problem-solving knowledge using 8D methodology.
• Strong analytical skills with experience in quality data trending and risk-based decision-making. Preferred ISO 13485 Lead Auditor or Internal Auditor qualification.
• Strong knowledge of applicable medical device regulations and standards, including FDA, EU MDR, ISO 13485, MDSAP, and local regulatory requirements.
• Effective project and change management skills.  Strong written and verbal communication skills.
• Ability to work effectively across different functions and levels of the organization.
• Strong organization and prioritization skills.

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.