{"id":4009193,"url":"https://alion.io/job/insulet-manager-quality-systems","title":"Manager, Quality Systems","company":{"id":5958,"name":"Insulet","domain":"insulet.com","url":"https://alion.io/company/insulet","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":95,"open_postings":35,"ghost_share":0,"stale_share":0.171,"repost_share":0.057,"time_to_fill_p50_days":32,"computed_at":"2026-11-10T06:52:35Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Gelang Patah, Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-11-10T09:03:16Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-10T09:03:16Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Job Summary\nPosition Overview:The Quality System Manager leads the Quality Management System (QMS) for the Insulet Malaysia manufacturing site and all its key processes.\nReporting 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.\n\nResponsibilities:\nQuality Management SystemLead the implementation, maintenance, and continuous improvement of the QMS at the Malaysia site.\nEnsure local quality system processes are aligned with global procedures and applicable regulatory requirements.\nMonitor QMS effectiveness and partner with local and global teams to drive improvements and implement quality system initiatives across key processes.\n\nChange Order & Document ControlOversee change order and document control activities, ensuring documents and changes are properly reviewed, approved, implemented, and maintained.\nAssess quality system changes for compliance, implementation, and training impact.\nEnsure timely implementation of quality system and document changes.\n\nQuality AuditingManage the site quality audit program, including internal quality system and process audits.\nSupport regulatory, certification, corporate, and customer audits and ensure findings are appropriately addressed.\nMaintain site readiness for regulatory inspections and quality system audits by conducting period audits on key processes.\n\nCAPA ManagementOversee the site CAPA process, including investigation, root cause, action plans, effectiveness verification, and closure.\nMonitor CAPA performance, aging, recurring issues, and effectiveness.\nDrive timely resolution and escalation of significant quality system issues.\n\nQuality KPIs & MetricsEstablish and monitor quality system KPIs, metrics, and dashboards.\nMonitor quality system trends, performance, and compliance risks and drive improvement with process owners.\nSupport quality management review and other management reporting activities.\n\nRegulatory ComplianceEnsure 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.\nSupport regulatory inspections and certification audits.\nPartner with Regulatory Affairs, Global Quality, and site teams to implement regulatory and quality system requirements and maintain inspection readiness.\n\nLeadership & CollaborationLead and develop the Quality Systems team and promote a culture of quality, compliance, and continuous improvement.\nCollaborate with Operations, Manufacturing, Engineering, Regulatory Affairs, Supplier Quality, and other functions.\nPartner with Global Quality teams and communicate quality system performance, risks, and improvement priorities to key stakeholders.\n\nQualifications & Experience\nBachelor’s Degree in engineering, science, quality management, or related technical discipline.\nMinimum 8 years of quality assurance or quality systems experience, preferably within the medical device industry.\nStrong knowledge and practical experience with ISO 13485 and medical device quality management systems. MDSAP and EU MDR 2017/745 will be advantages.\nExperience with CAPA, quality auditing, change control, document control, quality metrics, MSA, SPC and regulatory compliance.\nExperience managing regulatory and certification audits.\nPrevious people management or team leadership experience.\nExperience with electronic quality management systems and working with local and global teams is preferred.\n\nSkills & Competencies:\nStrong quality systems, regulatory, root cause analysis, and problem-solving knowledge using 8D methodology.\nStrong analytical skills with experience in quality data trending and risk-based decision-making. Preferred ISO 13485 Lead Auditor or Internal Auditor qualification.\nStrong knowledge of applicable medical device regulations and standards, including FDA, EU MDR, ISO 13485, MDSAP, and local regulatory requirements.\nEffective project and change management skills. Strong written and verbal communication skills.\nAbility to work effectively across different functions and levels of the organization.\nStrong organization and prioritization skills.\nInsulet 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.\nWe are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!","description_format":"text","description_chars":5024,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Diabetes Devices"],"lifecycle":[{"event":"open","at":"2026-11-10T09:03:16Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":32,"reasons":["conf:4","win:early","comp:brand"],"computed_at":"2026-11-10T13:20:28Z"},"pay":null,"html_url":"https://alion.io/job/insulet-manager-quality-systems","json_url":"https://alion.io/job/insulet-manager-quality-systems.json","meta":{"generated_at":"2026-11-10T13:20:28Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":31015,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5958},"rest":"https://alion.io/mcp/rest/get_company?id=5958"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Finsulet-manager-quality-systems"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Finsulet-manager-quality-systems"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Finsulet-manager-quality-systems"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/insulet-manager-quality-systems\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Finsulet-manager-quality-systems"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4009193}},{"tool":"search_jobs","arguments":{"company":"insulet.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4009193},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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