{"id":2890899,"url":"https://alion.io/job/freudenberg-sr-quality-engineer-medical-manufacturing","title":"Sr. Quality Engineer - Medical Manufacturing","company":{"id":5091,"name":"Freudenberg","domain":"freudenberg.com","url":"https://alion.io/company/freudenberg","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":183,"ghost_share":0,"stale_share":0.995,"repost_share":0,"time_to_fill_p50_days":27,"computed_at":"2026-10-29T05:49:05Z"}},"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":["Baldwin Park, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":95000,"max":115000,"currency":"USD","period":"year","gross":null,"usd_annual":115000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-07-14T00:00:00Z","employer_posted_date":"2026-07-14","last_verified_at":"2026-10-29T18:10:49Z","board_verified":true,"closed_at":null,"days_open":107,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":107},"description":"Working at Freudenberg: We will wow your world!\nResponsibilities:\nSite Subject Matter Expert on numerous ISO elements and champion site-wide standardization and continuous improvement initiatives. Has the ability to balance compliance with lean systems to support business.\n\nApply statistical tools (Minitab, Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, improve process capability, and support lean manufacturing and risk reduction initiatives.\n\nUtilize statistical tools to support the optimization of processes.\n\nCreate and ensure project quality planning documentation, required, sampling plan, process controls, early launch activities, monitoring activities to ensure compliance with customer project requirement.\n\nLead and collaborate cross-functionally with engineering, operations, quality /regulatory affairs, customers and suppliers to address quality related issues.\n\nAbility to manage CAPA Review Board, provide working solutions that meets compliance and business needs & provide summary of issues to senior management.\n\nLead and mentor Quality Engineers and Technicians, providing technical guidance, developing junior talent, and ensuring effective daily support for production, process improvement, and customer satisfaction.\n\nLead New Product Introduction (NPI) Quality Activities and design transfer activities, including design verification, process validation (IQ/OQ/PQ), risk management (FMEA), and compliance with regulatory standards.\n\nKnown by the site as the go to person to address the specific area.\n\nAbility to use current site knowledge and support other sites helping them to address their site concerns.\n\nLead supplier quality activities such as supplier selection, qualification, documentation, audits, quality agreement, coordination of supplier-driven product/process changes.\n\nLead internal and external audits, manage external auditors, oversee internal audit program and report on quality system compliance to site leadership with recommendation for area requiring improvements.\n\nLead and collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers to ensure all change related items are adequately assessed, documented and tested as required.\n\nQualifications:\nBachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.\n\n8+ years’ quality engineering experience in the medical device industry.\n\nUnderstanding of statistical methods, process control, and the use of quality tools such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, SPC, as well as GD&T and fixturing.\n\nDemonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.\n\nAdvanced understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.\n\nExtensive knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States, MDSAP).\n\nDemonstrated ability to lead internal and external audits and inspections effectively, including leading preparations and addressing findings.\n\nExpertise in conducting thorough root cause analyses for complex quality issues and developing effective CAPAs.\n\nExperience with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria.\n\nPreferred:\n5+ years’ experience in injection molding manufacturing operations or equivalent.\n\nProject management experience\n\nCertified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC).\n\nLean/Six Sigma certification\n\nThe expected salary range for this position is $95,000 to $115,000 annually, depending on skills, experience, and qualifications. \nThe Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.\nFreudenberg Medical LLC","description_format":"text","description_chars":4460,"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":["Mechanical Components & Fasteners","Advanced Materials","Plastics & Polymers","Automotive Components"],"lifecycle":[{"event":"open","at":"2026-10-20T02:21:13Z"}],"visa":[],"liveness":{"score":9,"band":"cold","label":"Long shot","p_open":1,"p_active":0.314,"p_room":0.28,"age_days":107,"expected_fill_days":27,"reasons":["conf:4","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":{"stated_usd_annual":115000,"is_top_pay":false},"html_url":"https://alion.io/job/freudenberg-sr-quality-engineer-medical-manufacturing","json_url":"https://alion.io/job/freudenberg-sr-quality-engineer-medical-manufacturing.json","meta":{"generated_at":"2026-10-29T18:39:50Z","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":27665,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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":5091},"rest":"https://alion.io/mcp/rest/get_company?id=5091"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ffreudenberg-sr-quality-engineer-medical-manufacturing"},{"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%2Ffreudenberg-sr-quality-engineer-medical-manufacturing"},{"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%2Ffreudenberg-sr-quality-engineer-medical-manufacturing"},{"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/freudenberg-sr-quality-engineer-medical-manufacturing\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffreudenberg-sr-quality-engineer-medical-manufacturing"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2890899}},{"tool":"search_jobs","arguments":{"company":"freudenberg.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2890899},"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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