{"id":3795559,"url":"https://alion.io/job/insulet-supplier-quality-engineer","title":"Supplier Quality Engineer","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":"2026-11-07T05:47:08Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","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":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-11-05T09:16:03Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-07T03:56:00Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Summary\nResponsibilities:Reporting directly to the Manager, Supplier Quality, the Engineer, Supplier Quality is responsible to support the selection, qualification, and management of suppliers. Closely works with suppliers to ensure product/service quality meets lnsulet requirements. Interfaces with other Insulet departments/functions as well as with suppliers and other external parties on issues related to product/service quality. Effectively communicates Quality metrics through supplier scorecards and Management Review to the organization, suppliers, and Executive Management.\nMaintain approved supplier list and supplier history records in accordance with quality system requirements.\nAssist with the qualification of new suppliers, new components, and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of plans and requirements for such qualifications.\nMaintains accuracy of Supplier Audit Reports and Supplier Profile\nDevelop and maintain the Supplier Audit Schedule to ensure supplier audits are scheduled per internal procedure.\nPlans and conducts scheduled audits of suppliers to assess compliance with lnsulet Requirements.\nPrepares Audit Reports to document audit findings and observations.\nCommunicates quality issues to suppliers as needed and provides assistance to develop corrective actions.\nInitiate and follow up on supplier CAPA for both audit deficiencies and internal non-conformances to ensure timely closure and effectiveness.\nGenerates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility.\nTracks and trends supplier performance via supplier scorecards, taking remedial action as needed.\nConduct and assist with internal audits.\nAssist or leads CAPA evaluation and closure as related to the supplier quality processes and or supplier performance.\nParticipate in developmental and departmental training.\nSupport Site during external audits (i.e. BSI, FDA, Customer).\nPerforms other duties as required.\nRequirements\nBachelor's degree (preferably science or engineering discipline) required.\n2 to 4 years of experience in quality in the medical device industry\nFluent in both English and Malay language.\nAbility to communicate and work effectively at multiple levels within the organization and with external business partners.\nGood interpersonal skills in dealing with suppliers, peers and other functional areas.\nWorking knowledge of ISO 13485 quality system standards\nAuditor training certification to ISO 13485, 17025 or other industry QMS Standard preferred.\nThe ability to prioritize multiple competing deliverables simultaneously.\n• Must be proficient in Word, Excel, Outlook and Power Point.\n\nPosition Overview:\nThis position is responsible for Design Control to ensure current products and new projects meet the regulatory and quality requirements for medical devices. Interfaces with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support. Effectively communicate design and development regulations, optimizing development, review and/or approval of design documents and protocols and ensuring ambiguities and conflicting requirements are resolved are critical to the success of the position.\nResponsibilities:\nResponsible for Design Control initiatives to develop appropriate Design History File documents. Review and approve new product documentation, as required.\nCollaborate with Project Management to optimize Design Control process and develop Sustaining Quality Engineering process.\nReview and approve Design Control documents and protocols.\nServe as the Design Control expert to organization.\nDevelop and deliver Design control training for organization.\nSupport CAPA activities\nSupport Risk Management activities and ensure compliance to standards and regulation\nPerforms other duties as assigned. Education and Experience: Minimum Requirements:\nBS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience.\nA minimum of 2-5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.\nExperience in the development and implementation of effective Design Control Systems.\nWorking knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices - Quality management systems, and ISO 14971 Medical devices - Application of risk management to medical devices.\nWorking knowledge of EN 60601, Safety requirements for medical electrical systems.\nWorking knowledge of ISO 62304, Medical Device Software - Software Life Cycle Process\nFluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint).\nDemonstrated experience organizing and maintaining large documentation sets.\nAbility to follow up with task owners to close out open items.\nFamiliarity with structured phase-gate product development processes.\nFamiliarity with FDA, ISO, and other international regulatory requirements. Preferred Skills and Competencies:\nEffective verbal and written communication skills.\nExperience collaborating and communicate with individuals at multiple levels in an organization.\nAbility to organize and judge priorities.\nAbility to generate and maintain accurate records.\nSkilled in computer use including word processing, spreadsheet, and database applications.\nAble to work effectively in a high-stress, high-energy environment. Physical Requirements:\nTravel as required to support business needs\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":6330,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"Malay","level":"Upper-Intermediate (B2)","optional":false},{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Diabetes Devices"],"lifecycle":[{"event":"open","at":"2026-11-05T09:16:03Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":1,"expected_fill_days":32,"reasons":["conf:1","velocity","win:early","comp:junior,brand"],"computed_at":"2026-11-07T05:47:08Z"},"pay":null,"html_url":"https://alion.io/job/insulet-supplier-quality-engineer","json_url":"https://alion.io/job/insulet-supplier-quality-engineer.json","meta":{"generated_at":"2026-11-08T02:50:44Z","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":6086,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-09T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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-supplier-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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-supplier-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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-supplier-quality-engineer"},{"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-supplier-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Finsulet-supplier-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3795559}},{"tool":"search_jobs","arguments":{"company":"insulet.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3795559},"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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