{"id":1759303,"url":"https://alion.io/job/insulet-manager-operations-quality-npi-programs-hybrid-acton","title":"Manager, Operations Quality - NPI Programs (Hybrid - Acton)","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":93,"open_postings":26,"ghost_share":0,"stale_share":0.231,"repost_share":0.115,"time_to_fill_p50_days":28,"computed_at":"2026-10-20T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":110900,"max":166325,"currency":"USD","period":"year","gross":null,"usd_annual":166325},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-03T12:08:55Z","employer_posted_date":"2026-10-03","last_verified_at":"2026-10-20T16:56:20Z","board_verified":true,"closed_at":null,"days_open":17,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":17},"description":"Job Summary\nJoin a highly visible leadership role where you will shape quality strategy for next-generation medical device products from early development through commercialization. As the Operations Quality Lead, you will lead both Manufacturing Quality and Supplier Quality activities, build and develop a high-performing quality team, and partner closely with R&D, Engineering, Operations, and suppliers to ensure compliant, scalable, and production-ready processes. This position offers the opportunity to drive supplier readiness, pilot manufacturing, clinical builds, and manufacturing transfer while influencing key quality decisions in a fast-paced, innovation-focused environment. Ideal candidates will bring expertise in quality engineering, supplier quality, FDA/ISO 13485 compliance, and NPI programs, along with a passion for leadership, problem-solving, and building robust quality systems that support successful product launches.\n\nPosition Overview:\n The Operations Quality Lead, NPI Programs is responsible for leading Operations Quality support across Manufacturing Quality and Supplier Quality activities for early-stage product development, supplier readiness, and pilot manufacturing operations.\nThis role serves as the single Operations Quality point of contact for manufacturing quality systems and supplier quality engineering support, ensuring prototype, pilot, clinical, and early commercial builds are compliant, well-controlled, and supported by capable suppliers, inspection strategies, and scalable quality processes.\nWorking closely with R&D, Manufacturing Engineering, Operations, Global Quality Engineering, and Global Supplier Quality, this role ensures builds are executed in compliance with design controls, supplier controls, documentation requirements, and regulatory standards while building the foundation for scalable, production-ready quality systems.\nA critical responsibility is building and leading a small Operations Quality team that can cover Manufacturing Quality and Supplier Quality needs while maintaining dotted-line alignment to the global Quality Engineering and Supplier Quality organizations.\nResponsibilities:\nServe as the Operations Quality lead for Manufacturing Quality and Supplier Quality Engineering support across early-stage development, supplier readiness, pilot manufacturing, clinical builds, and manufacturing transfer\nBuild, manage, and develop a small team responsible for covering Manufacturing Quality and Supplier Quality activities for NPI programs\nMaintain strong dotted-line relationships with Global Quality Engineering and Global Supplier Quality to ensure alignment with enterprise standards, escalation paths, and functional best practices\nOwn quality engineering workstreams for prototype, pilot, clinical, and early production builds, ensuring compliance with design controls, supplier controls, and quality system requirements\nDefine and implement inspection, test, incoming quality, and supplier release strategies for development and clinical stage builds \nEstablish and maintain control plans, procedures, work instructions, inspection plans, supplier quality plans, and acceptance criteria to support evolving pilot line and supplier processes\nEnsure builds meet DHF/DHR requirements, including inspection readiness, traceability, lot release, supplier documentation, and quality records required for clinical use\nLead in-process, incoming, and supplier inspection strategies, including test method development, validation, measurement system analysis, and component release readiness\nDrive root cause investigation, non-conformance disposition, supplier quality issue resolution, and corrective actions across development builds, pilot operations, and supplied components\nPartner with suppliers, R&D, Manufacturing Engineering, Operations, and Quality functions to ensure designs, supplied components, and manufacturing processes are manufacturable, inspectable, scalable, and compliant\nPerform data analysis and trending to inform design decisions, supplier performance, process improvements, and risk mitigation\nSupport risk management activities, including DFMEA, PFMEA, supplier risk assessments, and control strategies aligned to product and process maturity\nSupport validation of pilot line equipment, supplier processes, inspection methods, and manufacturing processes with alignment to future production readiness\nDefine and execute Operations Quality strategy for transition from pilot manufacturing and supplier readiness into commercial production\nTrain and guide cross-functional teams while ensuring compliance with FDA, ISO 13485, supplier quality, and GMP requirements Key Decision Rights:\nOwnership of the Operations Quality strategy spanning Manufacturing Quality and Supplier Quality support for NPI programs\nDecision-making on inspection approach, supplier quality plans, control framework, acceptance criteria, and quality readiness for pilot, clinical, and pre-production builds\nAuthority to disposition non-conforming product generated during development and pilot operations, in alignment with applicable quality procedures and functional quality partners\nEscalation ownership for supplier quality issues, manufacturing quality risks, and readiness gaps impacting clinical builds or manufacturing transfer\nInput into design control deliverables, supplier readiness, verification strategies, process validation, and manufacturing transfer readiness Required Leadership/Interpersonal Skills & Behaviors:\nPeople leader who can build capability, set priorities, coach team members, and create clear ownership across Manufacturing Quality and Supplier Quality activities\nStrategic thinker who can translate evolving product, process, and supplier requirements into practical, scalable quality systems\nStrong cross-functional collaborator across R&D, Manufacturing Engineering, Operations, Global Quality Engineering, Global Supplier Quality, and external suppliers\nDemonstrated ability to operate effectively in early-stage, ambiguous development and supplier readiness environments\nData-driven and detail-oriented, with strong problem-solving, prioritization, and escalation management capability\nAbility to influence design, process, supplier, and quality decisions through functional partnership and dotted-line alignment\nDrives clarity, structure, and discipline in fast-paced pilot manufacturing, supplier development, and commercialization environments Required Skills and Competencies:\nExperience leading Manufacturing Quality and/or Supplier Quality Engineering activities in a regulated manufacturing environment\nExpertise in inspections, incoming quality, supplier quality controls, test method validation, and measurement system analysis\nExperience with development-phase quality engineering, including design controls, DHF/DHR, supplier readiness, and clinical build support\nWorking knowledge of FDA QSR (21 CFR 820), ISO 13485, GMP, and supplier quality requirements\nExperience supporting manufacturing, process development, supplier development, and early-stage production environments\nFamiliarity with equipment, process, inspection method, and supplier process validation activities\nExperience working with inspection technologies, metrology, vision systems, supplier inspection methods, and incoming acceptance processes\nStrong analytical, problem-solving, people leadership, and cross-functional execution skills Education and Experience:\nBS in Engineering or related technical discipline with 6+ years of experience in quality engineering, manufacturing quality, supplier quality, or operations quality in a regulated industry\nPrior people leadership, technical leadership, or demonstrated ability to build and lead a small cross-functional quality team \nExperience supporting NPI programs, pilot line operations, supplier readiness, and development builds required\nMedical device experience strongly preferred, particularly supporting design controls, clinical builds, supplier quality, and manufacturing transfer Additional Information:\nAble to work in a Class 8 Cleanroom Environment as needed\nRole is based in Acton and the ideal candidate will be in office a minimum of 4 days a week\nTravel up to 10%, including international travel to equipment vendors and manufacturing sites\nNOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid\nAdditional Information:\n\nCompensation & Benefits:\n\nFor U.S.-based positions only, the annual base salary range for this role is $110,900.00 - $166,325.00\n\nThis position may also be eligible for incentive compensation.\n\nWe offer a comprehensive benefits package, including:\n• Medical, dental, and vision insurance\n• 401(k) with company match\n• Paid time off (PTO)\n• And additional employee wellness programs\n\nApplication Details:\nThis job posting will remain open until the position is filled.\nTo apply, please visit the Insulet Careers site and submit your application online.\n\nActual pay depends on skills, experience, and education.Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.\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!\nAt Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.\n(Know Your Rights)","description_format":"text","description_chars":10643,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Hybrid work","Vision insurance","Wellness"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Diabetes Devices"],"lifecycle":[{"event":"open","at":"2026-10-03T12:08:55Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 37 · green card filings: 17","filings_12m":37,"filings_prev_12m":51,"green_card_filings_12m":17,"median_offered_wage_usd":152778,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":74,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.824,"p_room":0.9,"age_days":16,"expected_fill_days":28,"reasons":["conf:7","velocity","win:mid","comp:brand"],"computed_at":"2026-10-20T05:45:00Z"},"pay":{"stated_usd_annual":166325,"is_top_pay":true},"html_url":"https://alion.io/job/insulet-manager-operations-quality-npi-programs-hybrid-acton","json_url":"https://alion.io/job/insulet-manager-operations-quality-npi-programs-hybrid-acton.json","meta":{"generated_at":"2026-10-20T21:00:07Z","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":24408,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"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-manager-operations-quality-npi-programs-hybrid-acton"},{"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-manager-operations-quality-npi-programs-hybrid-acton"},{"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-manager-operations-quality-npi-programs-hybrid-acton"},{"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-operations-quality-npi-programs-hybrid-acton\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Finsulet-manager-operations-quality-npi-programs-hybrid-acton"}]}