{"id":2533506,"url":"https://alion.io/job/fresenius-medical-care-quality-engineer-2","title":"Quality Engineer","company":{"id":7235,"name":"Fresenius Medical Care","domain":"freseniusmedicalcare.com","url":"https://alion.io/company/fresenius-medical-care","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":100,"open_postings":412,"ghost_share":0,"stale_share":0.109,"repost_share":0.032,"time_to_fill_p50_days":13,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Vršac, Serbia"],"countries":["RS"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":36000,"max_usd":79000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":5668},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-14T13:36:44Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-11-05T19:14:55Z","board_verified":true,"closed_at":null,"days_open":22,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":22},"description":"Quality Engineer\nAt Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision-“Creating a future worth living. For patients. Worldwide. Every day.”-we work with purpose and compassion, supported by a global team of over 110,000 employees.\nWithin our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.\nOur values guide how we work:\nWe Care for our patients, each other, and our communities\nWe Connect across teams and borders to deliver excellence together\nWe Commit to doing things the right way- growing with purpose and leading kidney care with integrity and innovation\nSystems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations.\nAs a Quality Engineer, you will play a key role in ensuring product quality, process reliability, and compliance within our manufacturing environment. You will investigate quality issues, support corrective and preventive actions, analyze manufacturing data, and drive continuous improvement initiatives. Working closely with cross-functional teams, you will help maintain high quality standards while supporting innovation, operational excellence, and patient safety throughout the product lifecycle.\nYour Responsibilities:\nInvestigate and resolve product, process, and manufacturing quality issues using structured problem-solving methodologies such as 8D, 5 Why, Fishbone, and Root Cause Analysis.\nSupport and execute CAPA, nonconformance, deviation, and corrective action activities in compliance with the Quality Management System.\nAnalyze quality and manufacturing data to identify trends, process variation, recurring issues, and opportunities for improvement.\nProvide technical support for customer complaint investigations and collaborate with cross-functional teams to determine root causes and implement effective solutions.\nApply statistical quality tools such as SPC, process capability analysis, Pareto analysis, trend analysis, and measurement system analysis to support data-driven decision-making.\nParticipate in continuous improvement initiatives focused on defect prevention, process robustness, variation reduction, and operational excellence.\nSupport new product introductions, design changes, process improvements, technology transfers, and manufacturing transfer projects.\nContribute to risk management activities, including FMEA, process controls, validation activities, and quality planning.\nCollaborate closely with Manufacturing, Process Engineering, Operations, Supply Chain, Regulatory Affairs, and Quality teams to improve product and process performance.\nEnsure compliance with applicable quality standards and regulatory requirements, including ISO 13485 and ISO 14971.\nSupport internal and external audits by providing technical documentation, investigation records, and quality evidence.\nPromote best practices and knowledge sharing across manufacturing sites to support standardized quality engineering processes.\nYour Profile:\nBachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical & Electronics Engineering, Chemical Engineering, Industrial Engineering, Materials Science, or a related technical discipline.\nMinimum 3 years of experience in Quality Engineering, Manufacturing Engineering, Process Engineering, or a related role within a regulated manufacturing environment. Medical device industry experience is preferred.\nExperience with nonconformance management, CAPA processes, root cause analysis, investigations, and corrective actions.\nKnowledge of Quality Management Systems and quality engineering principles; familiarity with ISO 13485 and ISO 14971 is preferred.\nExperience using quality and statistical tools, including SPC, process capability analysis, Pareto analysis, and trend analysis.\nStrong analytical, problem-solving, and data interpretation skills.\nExcellent communication and cross-functional collaboration abilities.\nLean Six Sigma Green Belt certification or equivalent experience is considered an asset.\nExperience with process validation, equipment qualification, manufacturing transfers, extrusion, injection molding, automation, or assembly processes is preferred.\nProficiency in Microsoft Office applications and statistical software (Minitab preferred).\nWillingness to travel domestically and internationally as required.\nBased in Vršac or willing to relocate.\nOur Offer For You:\nThere is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.\nWhether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world\nIndividual opportunities for self-determined career planning and professional development\nA corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one\nA large number of committed people with a wide range of skills, talents and experience\nThe benefits of a successful global corporation with the collegial culture of a medium-sized company","description_format":"text","description_chars":6040,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Dialysis & Kidney Care","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-14T13:36:44Z"}],"visa":[],"liveness":{"score":34,"band":"fade","label":"Fading","p_open":1,"p_active":0.767,"p_room":0.45,"age_days":21,"expected_fill_days":13,"reasons":["conf:0","velocity","win:tail","comp:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/fresenius-medical-care-quality-engineer-2","json_url":"https://alion.io/job/fresenius-medical-care-quality-engineer-2.json","meta":{"generated_at":"2026-11-05T20:17:05Z","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":27502,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":7235},"rest":"https://alion.io/mcp/rest/get_company?id=7235"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ffresenius-medical-care-quality-engineer-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%2Ffresenius-medical-care-quality-engineer-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%2Ffresenius-medical-care-quality-engineer-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/fresenius-medical-care-quality-engineer-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffresenius-medical-care-quality-engineer-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2533506}},{"tool":"search_jobs","arguments":{"company":"freseniusmedicalcare.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2533506},"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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