{"id":552565,"url":"https://alion.io/job/roechling-engineer-quality","title":"Engineer, Quality","company":{"id":450557,"name":"Röchling","domain":"roechling.com","url":"https://alion.io/company/roechling-2","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":86,"open_postings":18,"ghost_share":0,"stale_share":0.556,"repost_share":0,"time_to_fill_p50_days":53,"computed_at":"2026-10-28T05:59:10Z"}},"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":["Rochester, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":79000,"max_usd":148000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-04T00:00:00Z","employer_posted_date":"2026-09-04","last_verified_at":"2026-10-28T02:07:58Z","board_verified":true,"closed_at":null,"days_open":54,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":54},"description":"At Röchling Medical, we're united by a shared purpose: improving lives through innovation in health. As a trusted partner to leading pharmaceutical, biotech, and medical device companies around the world, we develop customized products and solutions that help advance patient care and save lives.\nYour role\nSupport Engineering Development and Validation activities.IQ, OQ, PQ SubmissionsDocument IQ, OQ, PQ Protocols\nDocument IQ, OQ, PQ Submissions\n\nSoftware validation\nAutomated program validation\nMeasurement System Analysis (MSA) / Gage R&R / Measurement System Validation\nCleanroom validation\nPerform Data Analysis using MinitabCapability Analysis\nANOVA Studies\n\nDevelop Qualification DocumentationDevelop Control Plans\nDevelop PFMEA and risk documentation\nDevelop Process Flow\n\nInvestigate Product and Process Nonconformities, Complaints, and CAPAs using Problem Solving & Root-cause Analysis Tools:5-why Analysis\nFishbone Analysis\nScheduling Brainstorm sessions\nDocumenting Continuous Improvement Activities\nTracing production history throughout ERP, and other systems\n\nSupport AuditsInternal Auditor\nSubject Matter Expert during external audits\nBackroom support during audits\nPerform supplier audits\nLead process audits\n\nMonitor and analyze quality performance and present metrics\nDevelop and optimize inspection strategies and methodsDevelop sampling plans\nSelect appropriate inspection methods & equipment\nGage design and development\nData collection strategies\n\nDrive Quality and Improvement projectsComplete change orders\nReview and submit supplier change requests/ notifications\n\nWrite and revise Forms, Work Instructions and SOP’sTrain others on process changes\n\nWork with suppliers to enhance the supply chainCommunicate and manage MRR - Material Rejection Reports to suppliers\nDrive supplier improvement using the SCAR process\nEvaluate and qualify new suppliers\n\nCommunicate directly with customers throughoutProject meetings\nQuality issues\n\nRequired Skills/Abilities:\nExcellent verbal and written communication skills.\nExcellent interpersonal and customer service skills.\nExcellent organizational skills and attention to detail.\nStrong understanding of FDA (21 CFR Part 820/QMSR), and ISO 13485 Quality System\nStrong analytical and problem-solving skills.\nStrong leadership skills.\nAbility to prioritize tasks and to delegate them when appropriate.\nAbility to function well in a high-paced and at times stressful environment.\nAbility to simplify complex situations and present them with an appropriate level of detail\nAbility to analyze risk and make decisions\nProficient with statistical software\nProficient print reading skills including GD&T\nAbility to travel as required to Suppliers, Customers, and other events. Up to 10%\nEducation and Experience:\nRequired\nBachelor's degree in Engineering, Quality, Manufacturing, or related technical discipline.\n5 years of Quality Engineering experience in a regulated manufacturing environment.\nPreferred\nMedical device manufacturing experience.\nExperience with injection molding and process validation.\nExperience supporting ISO13485 audits.\nASQ Certified Quality Engineer (CQE).\nLean Six Sigma Green Belt or Black Belt certification.\nYour benefits\nHealth Management: Your health and well-being are important to us. Take advantage of our diverse health offerings, such as the health clinic.\n\nTraining and Development: Our focus is on the continuous growth of our team members. We want to ensure that everyone can reach their full potential, which is why we offer tailored training programs for various roles. This helps you achieve peak performance and boosts your professional success!\n\nFood: Our sites offer vending machines with a variety of snacks and food options for you to enjoy - perfect for added flexibility during shift work, ensuring convenient access to refreshments at any time.\n\nFlexibility: Flexibility leads to efficiency - that’s what we believe. That's why mobile work is possible.","description_format":"text","description_chars":3959,"description_truncated":false,"requirements":{"experience_years_min":5,"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":["Plastics & Polymers","Automotive Components","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-09-08T17:26:52Z"}],"visa":[],"liveness":{"score":30,"band":"fade","label":"Fading","p_open":1,"p_active":0.537,"p_room":0.55,"age_days":54,"expected_fill_days":53,"reasons":["conf:3","stale_co","win:tail"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/roechling-engineer-quality","json_url":"https://alion.io/job/roechling-engineer-quality.json","meta":{"generated_at":"2026-10-28T14:01:33Z","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":19067,"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":450557},"rest":"https://alion.io/mcp/rest/get_company?id=450557"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Froechling-engineer-quality"},{"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%2Froechling-engineer-quality"},{"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%2Froechling-engineer-quality"},{"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/roechling-engineer-quality\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Froechling-engineer-quality"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":552565}},{"tool":"search_jobs","arguments":{"company":"roechling.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":552565},"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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