{"id":1912229,"url":"https://alion.io/job/insulet-director-quality-operations-2","title":"Director, Quality Operations","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":91,"open_postings":31,"ghost_share":0.032,"stale_share":0.226,"repost_share":0.097,"time_to_fill_p50_days":27,"computed_at":"2026-10-13T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Heredia, Costa Rica"],"countries":["CR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":55000,"max_usd":131000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":676},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-05T15:05:32Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-12T23:41:26Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"Job Summary\nWork Arrangement: Due to the launch of our new greenfield site, this role will start as remote. Candidates are expected to transition to an onsite work arrangement once the facility is readyRequired Experience & Qualifications\nBachelor's degree in Engineering, Science, or related discipline; advanced degree preferred.\n12+ years of progressive medical device quality leadership experience, including significant manufacturing quality responsibility.\n10+ years leading managers and professional quality organizations in regulated environments.\nStrong knowledge of FDA Quality System Regulations, ISO 13485, MDR, risk management, validation, and quality engineering principles.\nExperience supporting site start-ups, transfers, rapid-growth operations, or large-scale manufacturing expansions preferred.\n• Demonstrated ability to lead through inspections, customer audits, regulatory audits, and organizational change.\n\nPosition Overview\nThe Director, Quality Operations provides strategic and operational leadership for all Quality functions at Insulet Costa Rica. This role is accountable for product quality, regulatory compliance, quality systems effectiveness, and quality culture across a large-scale medical device manufacturing site. The position serves as a key member of the site leadership team, ensuring compliance with FDA, ISO 13485, MDR, and applicable global regulations while enabling business growth, operational excellence, and successful site expansion.\nKey Responsibilities\nLead Quality Engineering, Quality Assurance, Quality Control, Incoming Quality, and Quality Systems functions across the Costa Rica manufacturing site.\nPartner with Global Quality, Operations, Supply Chain, Regulatory, and Engineering teams to ensure alignment with Insulet's global quality standards and strategic objectives.\nDevelop and execute the site Quality strategy aligned with global Quality and business objectives.\nServe as the primary Quality representative during FDA inspections, MDSAP audits, ISO 13485 certification audits, customer audits, and corporate assessments.\nProvide executive oversight of CAPA, nonconformance management, management review, audits, complaints, validation, environmental monitoring, training, and release processes.\nLead quality readiness activities for site expansion, capacity growth, inspections, certifications, and commercialization programs.\nEnsure robust risk management practices and data-driven decision making throughout manufacturing operations.\nOwn multiple quality budgets and establish performance metrics that improve customer satisfaction, compliance, and operational effectiveness.\nLeadership Competencies (Aligned to Insulet Leadership Model)\nStrategic Thinking: Establishes a long-term quality vision that supports business growth, emerging technologies, and customer requirements.\nGlobal Perspective: Operates effectively within a global matrix organization and drives harmonization of quality practices across regions.\nInnovation: Champions quality innovation, digitalization, automation, and continuous improvement initiatives.\nFinancial Acumen: Balances compliance, risk, operational performance, and cost effectiveness when making decisions.\nCustomer Focus: Ensures quality systems and manufacturing processes consistently meet customer and patient expectations.\nAnalysis and Problem Solving: Utilizes statistical, operational, and quality data to identify root causes and implement sustainable solutions.\nExecution Excellence: Drives accountability, speed, and disciplined execution against commitments and quality objectives.\nRelationship Building: Builds strong partnerships across functions, cultures, and organizational levels.\nPeople Development: Develops future leaders through coaching, succession planning, talent reviews, and capability building.\nCommunication: Clearly communicates quality risks, priorities, and strategic objectives to executive leadership and teams.\nEngagement: Creates a culture of inclusion, accountability, ownership, and continuous improvement.\nAdaptability and Courage: Leads effectively through ambiguity, growth, audits, organizational change, and business challenges.\nInfluence and Collaboration: Gains alignment across stakeholders without direct authority and promotes effective cross-functional decision making.\nRequired Experience & Qualifications\nBachelor's degree in Engineering, Science, or related discipline; advanced degree preferred.\n12+ years of progressive medical device quality leadership experience, including significant manufacturing quality responsibility.\n10+ years leading managers and professional quality organizations in regulated environments.\nStrong knowledge of FDA Quality System Regulations, ISO 13485, MDR, risk management, validation, and quality engineering principles.\nExperience supporting site start-ups, transfers, rapid-growth operations, or large-scale manufacturing expansions preferred.\nDemonstrated ability to lead through inspections, customer audits, regulatory audits, and organizational change.\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":5635,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Costa Rica","iso":"CR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Diabetes Devices"],"lifecycle":[{"event":"open","at":"2026-10-05T15:05:32Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":7,"expected_fill_days":27,"reasons":["conf:6","velocity","win:early","comp:brand"],"computed_at":"2026-10-13T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/insulet-director-quality-operations-2","json_url":"https://alion.io/job/insulet-director-quality-operations-2.json","meta":{"generated_at":"2026-10-13T11:58:31Z","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":18625,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"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-director-quality-operations-2"},{"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-director-quality-operations-2"},{"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-director-quality-operations-2"},{"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-director-quality-operations-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Finsulet-director-quality-operations-2"}]}