Quality Systems Manager

Insulet Corporation

. Lead the Quality Management System for the Insulet Malaysia manufacturing site and its key processes .

Posted 11/10/2026full-timeGelang Patah • MalaysiaSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading and improving Quality Management Systems (QMS) in the medical device industry, ensuring compliance with ISO 13485 and applicable regulations. Proven ability to manage quality audits, CAPA processes, and cross-functional collaboration to drive quality initiatives and performance metrics.

Highest-signal resume keywords

ISO 13485 KnowledgeCAPA ManagementQuality Auditing ExperienceRegulatory Compliance ExpertiseTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemsRoot Cause AnalysisChange ControlDocument ControlQuality MetricsMSASPCQuality Data TrendingRisk-Based Decision-Making8D Methodology

Soft Skills

Effective CommunicationProject ManagementOrganizational SkillsProblem-SolvingCollaboration

Tools & Technologies

Electronic Quality Management Systems

Certifications & Qualifications

ISO 13485 Lead AuditorInternal Auditor Qualification

Industry Keywords

Medical Device RegulationsFDAEU MDRMDSAPQuality AssuranceQuality SystemsRegulatory AuditsQuality System KPIs

About the role

Key responsibilities & impact

Lead the Quality Management System for the Insulet Malaysia manufacturing site and its key processes
Implement, maintain, and continuously improve the QMS at the Malaysia site
Align local quality system processes with global procedures and applicable regulatory requirements
Monitor QMS effectiveness and drive quality system improvements and initiatives
Oversee change order and document control activities
Assess quality system changes for compliance, implementation, and training impact
Manage the site quality audit program and support regulatory, certification, corporate, and customer audits
Maintain site readiness for regulatory inspections and quality system audits
Oversee CAPA investigation, root cause analysis, action plans, effectiveness verification, and closure
Monitor CAPA performance, aging, recurring issues, and effectiveness
Establish and monitor quality system KPIs, metrics, and dashboards
Support quality management review and management reporting
Ensure QMS compliance with medical device regulations and standards
Lead and develop the Quality Systems team
Collaborate with Operations, Manufacturing, Engineering, Regulatory Affairs, Supplier Quality, and other functions
Partner with Global Quality teams and communicate performance, risks, and improvement priorities to stakeholders

Requirements

What you’ll need

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
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
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