Job Summary

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.