{"id":2997592,"url":"https://alion.io/job/fresenius-medical-care-quality-systems-engineer","title":"Quality Systems 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":395,"ghost_share":0,"stale_share":0.109,"repost_share":0.033,"time_to_fill_p50_days":13,"computed_at":"2026-11-02T06:13:15Z"}},"role":"Finance","role_family":"Finance","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Knoxville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":59000,"max_usd":113000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2171},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"FMEA","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-10-05T00:00:00Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-11-02T21:35:29Z","board_verified":true,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"PURPOSE AND SCOPE:\nResponsible for representing the sites quality initiatives and compliance objectives in the development of methods, procedures, validations and quality planning for the facility.\nPRINCIPAL DUTIES AND RESPONSIBILITIES:\nUnder close supervision, utilizes established procedures to perform routine assigned tasks and applies company policies and procedures to participate in the development, review, and improvement of the facility's Quality Plan and manufacturing processes. Participates in management of product Risk Management Files. Continually updates information and coordinates information exchange with other FMCNA facilities.\nUtilizes current acceptable industry/FDA requirements to justify, write, and implement process validation and GMP procedures. Drafts, reviews, and/or assists in the implementation of validation protocols, final validation reports, Quality System procedures, performance qualifications, and Engineering Change Orders (ECO). Maintains validation records and systems to keep ongoing process validations current and applicable to process.\nPerforms plant investigations into product complaints and prepares reports for review by Quality Manager prior to submittal to Corporate Quality Systems. Assists in drafting Corporate Material Review Board (MRB) request to deviate, when appropriate, from current corporate documents.\nAnalyzes processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures. Where failures and potential failures are identified, investigates and assists in making recommendations necessary to correct and prevent recurrence.\nUses appropriate statistical methodology, such as CpK and trend analysis, to assist in analyzing or reviewing manufacturing, quality, and/or laboratory data for recurring problems or the detection of negative trend. Establishes reports and procedures in conjunction with Process Engineering to assure system reliability and product quality. When recurring problems and/or negative trends are identified, recommends corrective action for problem resolution.\nReviews processing procedures in new and existing programs to assure enhanced quality and productivity while remaining in compliance with FDA/cGMP/QSR. Assists the Quality Systems and Production operations with compliance to QSR requirements.\nParticipates in management of the plant metrology program to assure all appropriate tooling is available for inspection and test, and that all calibration activities are performed when due.\nParticipates as a member of the facility's Audit Team in performing internal and external audits as required.\nAssists in providing in-house training (e.g., calibration, validations, batch production and operation of equipment) in conjunction with plant management to operators and other personnel, as assigned.\nParticipates in product design control activities for new product lines.\nConducts risk analysis (Fault Tree, FMEA, FMECA, HASAP or equivalent accepted methods) as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions.\nHas the authority to issue a STOP NOTICE to immediately stop production when a concern regarding possible production, stocking, or shipping of discrepant assemblies or product arises.\nBuilds stable working relationships internally. \nNormally receives specific, detailed instructions on all work. \nMay refer to senior staff, if applicable, for assistance with day-to-day problems that may arise. \nEscalates issues to supervisor/manager for resolution, as deemed necessary.\nReview and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.\nAssist with various projects as assigned by direct supervisor.\nOther duties as assigned.\nAdditional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.\nPHYSICAL DEMANDS AND WORKING CONDITIONS:\nThe physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nMay be required to sit and/or walk for considerable lengths of time. Bending to floor level is required.\nEDUCATION:\nBachelor's Degree required, preferably in Engineering, Science, Chemistry, or Biology. An Associate's Degree may be considered with additional years or relevant work experience.\nEXPERIENCE AND REQUIRED SKILLS:\n0 - 2 years' of combined Quality Engineering, process validation required. Pharmaceutical manufacturing, medical device manufacturing and/or laboratory (organic chemistry, analytical, and/or microbiology) experience preferred. With a Master's Degree no prior work experience may be necessary.\nKnowledge of process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GLP/CMP/QSR), Risk Management / HACCP concepts, statistical process control, and statistical problem solving. Also as applicable, strong knowledge of Health Canada GMP's.\nMust have good organizational skills and be able to perform work with little supervision. Position requires a mathematical aptitude with a good background in algebraic skills and statistical analysis skills. Knowledge of analytical laboratory methodologies is important.\nProfessional auditing certification (ASQ, CQA, RAB, or equivalent) preferred for audit responsibilities.\nFMCNA IMPAQ Associate or equivalent (i.e. Six Sigma Green Belt) qualification is preferred; professional quality science certifications (i.e. ASQ, CQE, CMQ/OE) desired.\nGood verbal and written communication skills to make oral presentations and write technical reports.\nFresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.\nFresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors","description_format":"text","description_chars":6305,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"associate","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Dialysis & Kidney Care","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-21T11:15:57Z"}],"visa":[],"liveness":{"score":15,"band":"cold","label":"Long shot","p_open":1,"p_active":0.523,"p_room":0.28,"age_days":28,"expected_fill_days":13,"reasons":["conf:4","velocity","win:tail","crowd:junior,brand"],"computed_at":"2026-11-02T06:13:15Z"},"pay":null,"html_url":"https://alion.io/job/fresenius-medical-care-quality-systems-engineer","json_url":"https://alion.io/job/fresenius-medical-care-quality-systems-engineer.json","meta":{"generated_at":"2026-11-03T01:23:12Z","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":1835,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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-systems-engineer"},{"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-systems-engineer"},{"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-systems-engineer"},{"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-systems-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffresenius-medical-care-quality-systems-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2997592}},{"tool":"search_jobs","arguments":{"company":"freseniusmedicalcare.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2997592},"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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