{"id":3192587,"url":"https://alion.io/job/penumbra-supplier-quality-engineering-manager-supplier-controls","title":"Supplier Quality Engineering Manager – Supplier Controls","company":{"id":4897,"name":"Penumbra","domain":"penumbrainc.com","url":"https://alion.io/company/penumbra","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"B","score":83,"open_postings":13,"ghost_share":0,"stale_share":0.692,"repost_share":0,"time_to_fill_p50_days":58,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Alameda, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":138000,"max":203000,"currency":"USD","period":"year","gross":null,"usd_annual":203000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-10-24T00:25:41Z","employer_posted_date":"2026-10-24","last_verified_at":"2026-10-28T11:53:22Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"General Summary\nWe are seeking an experienced Supplier Quality Engineering Manager to help manage our Supplier Controls. This position is responsible for the effective execution, oversight, and continuous improvement of supplier quality processes and controls that support manufacturing operations and regulatory compliance.\nThe manager will own key supplier quality processes, including Approved Supplier List (ASL) management, supplier onboarding and qualification controls, and supplier performance monitoring. This individual will ensure that established processes are consistently executed, appropriately controlled, and compliant with quality management system requirements while driving improvements that enhance efficiency, standardization, and operational effectiveness.\nThe role will play an important part in modernizing supplier quality processes and systems, leveraging enterprise platforms and cross-functional partnerships to simplify workflows, strengthen controls, and improve how supplier quality activities are managed. The manager will also lead a dedicated team of Supplier Quality Engineers supporting supplier quality operations and the needs of Operational Procurement across multiple manufacturing sites.\nThe successful candidate will bring strong supplier quality engineering fundamentals, practical experience managing quality processes, effective people leadership, and a continuous improvement mindset.\nPrimary Responsibilities\nSupplier Quality Controls\nOwn and manage supplier quality control processes, including ASL maintenance, supplier addition requests, supplier approval status, and associated supplier qualification controls.\nEnsure supplier onboarding, approval, and qualification activities are executed consistently, efficiently, and in accordance with established risk-based requirements and quality management system procedures.\nMaintain effective governance of supplier quality records, approval workflows, supplier status, and associated documentation to ensure traceability, accuracy, and regulatory compliance.\nEstablish and maintain standardized processes, clear accountability, and appropriate controls to ensure reliable execution and sustained compliance.\nMonitor process effectiveness, address execution gaps, and drive improvements in process adherence, turnaround times, and operational efficiency.\nSupplier Quality Process Improvement\nDrive the improvement and modernization of supplier quality processes to enhance efficiency, simplify workflows, strengthen controls, and support evolving business needs.\nImprove the utilization and effectiveness of enterprise systems, including SAP, AssurX, TrackWise, and other applicable quality management platforms, to support supplier quality activities.\nPartner with Quality Engineering leadership, IT, Quality Systems, and cross-functional stakeholders to identify improvement opportunities, define business requirements, and implement practical, sustainable solutions.\nSupport the transition of manual supplier quality activities to streamlined, electronically managed processes that maintain appropriate quality system controls and regulatory compliance.\nCoordinate process changes, system implementation activities, validation support, and associated QMS documentation updates with appropriate functional stakeholders.\nEnsure improvements are effectively implemented, adopted, and sustained through standardized practices, training, and ongoing process monitoring.\nSupplier Quality Performance Monitoring\nManage standardized processes for monitoring, tracking, and reporting supplier quality performance, including supplier nonconformances, corrective actions, supplier changes, and other established quality indicators.\nEnsure supplier quality data is accurate, consistent, and accessible to support supplier performance evaluations, trend analysis, and management decision-making.\nCollaborate with manufacturing sites to ensure consistent application of supplier quality processes, controls, and performance monitoring practices.\nSupport supplier quality activities across domestic and international manufacturing locations, including supplier onboarding, supplier-related requests, receiving quality issues, and supplier changes.\nPartner with site Quality Engineering, Incoming Quality Control, and Operational Procurement teams to address process inconsistencies and improve cross-site coordination.\nTeam Leadership\nLead, coach, and develop a team of Supplier Quality Engineers responsible for supplier controls and assigned operational support activities.\nProvide dedicated engineering support for Supplier Change assessments, incoming quality nonconformances, and other supplier quality activities in coordination with Supplier Quality Engineering leadership.\nEnsure timely, technically sound, and risk-based execution of assigned supplier quality activities in accordance with established procedures and quality system requirements.\nPartner closely with other SQE Managers and Operational Procurement to align priorities, balance resources, and support timely resolution of supplier quality needs.\nEstablish clear team expectations, develop employee capabilities, and foster a culture of accountability, collaboration, and continuous improvement.\nRequired Qualifications\nBachelor's degree in Engineering, Science, or a related technical discipline.\n8+ years of progressive experience in Supplier Quality Engineering, Quality Engineering, or related quality functions within a regulated manufacturing environment.\nStrong working knowledge of supplier quality management processes, including supplier qualification, supplier onboarding and approval, supplier controls, supplier performance monitoring, supplier changes, and nonconformance management.\nExperience managing or providing technical leadership to quality engineering teams.\nDemonstrated ability to manage quality processes, ensure procedural compliance, and drive improvements in operational execution.\nExperience working with ERP and/or electronic quality management systems in support of quality processes and controls.\nWorking knowledge of ISO 13485, FDA Quality Management System Regulation (QMSR), and applicable supplier control requirements.\nStrong organizational, analytical, communication, and cross-functional collaboration skills.\nPreferred Qualifications\nSupplier Quality Engineering experience in medical device manufacturing.\nExperience managing Approved Supplier Lists, supplier qualification records, supplier approval workflows, and related QMS processes.\nExperience with SAP, AssurX, TrackWise, MasterControl, or comparable enterprise and quality management systems.\nExperience improving quality workflows, defining business requirements, and supporting electronic system enhancements and implementation.\nExperience establishing or maintaining supplier performance metrics, scorecards, and quality reporting.\nExperience supporting supplier quality activities across multiple manufacturing locations.\nDemonstrated success improving quality process efficiency, standardization, and execution.\nASQ certification, Lean Six Sigma certification, or relevant continuous improvement training.\nLeadership Expectations\nThe Supplier Controls Manager is expected to demonstrate strong ownership of supplier quality processes, ensuring they are effectively executed, appropriately controlled, and continuously improved.\nThis individual should possess the technical judgment to evaluate supplier quality risks, the operational discipline to maintain reliable and compliant processes, and the initiative to improve and modernize established ways of working.\nSuccess in this role requires balancing daily supplier quality responsibilities with process improvement, effective cross-functional collaboration, employee development, and support for manufacturing operations.\nLocation and Salary\nLocation: Alameda, CA\nAnnual Base Salary Range: $138,000 to $203,000\nWe offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.\nWorking Conditions\nGeneral office, laboratory, and cleanroom environments\nWillingness and ability to work on site. May have business travel from 0% - 25%\nPotential exposure to blood-borne pathogens\nRequires some lifting and moving of up to 25 pounds\nMust be able to move between buildings and floors.\nMust be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.\nMust be able to read, prepare emails, and produce documents and spreadsheets.\nMust be able to move within the office and access file cabinets or supplies, as needed.\nMust be able to communicate and exchange accurate information with employees at all levels on a daily basis.","description_format":"text","description_chars":8893,"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":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-10-24T02:41:45Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 47 · green card filings: 16","filings_12m":47,"filings_prev_12m":31,"green_card_filings_12m":16,"median_offered_wage_usd":125040,"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":60,"band":"ok","label":"Likely open","p_open":1,"p_active":0.602,"p_room":1,"age_days":4,"expected_fill_days":58,"reasons":["conf:3","stale_co","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":203000,"is_top_pay":true},"html_url":"https://alion.io/job/penumbra-supplier-quality-engineering-manager-supplier-controls","json_url":"https://alion.io/job/penumbra-supplier-quality-engineering-manager-supplier-controls.json","meta":{"generated_at":"2026-10-28T16:09:11Z","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":21787,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"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":4897},"rest":"https://alion.io/mcp/rest/get_company?id=4897"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpenumbra-supplier-quality-engineering-manager-supplier-controls"},{"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%2Fpenumbra-supplier-quality-engineering-manager-supplier-controls"},{"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%2Fpenumbra-supplier-quality-engineering-manager-supplier-controls"},{"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/penumbra-supplier-quality-engineering-manager-supplier-controls\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpenumbra-supplier-quality-engineering-manager-supplier-controls"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3192587}},{"tool":"search_jobs","arguments":{"company":"penumbrainc.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3192587},"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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