{"id":196409,"url":"https://alion.io/job/fresenius-medical-care-quality-system-engineer","title":"Quality System 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":388,"ghost_share":0,"stale_share":0.106,"repost_share":0.034,"time_to_fill_p50_days":13,"computed_at":"2026-10-30T05:48:23Z"}},"role":"DevOps","role_family":"DevOps","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":["Zapopan, Mexico"],"countries":["MX"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-08-24T00:00:00Z","employer_posted_date":"2026-08-24","last_verified_at":"2026-10-30T19:03:08Z","board_verified":true,"closed_at":null,"days_open":67,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":67},"description":"Quality System 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.\nOur manufacturing plant in Guadalajara, Mexico plays a key role in our global operations. The site specializes in the production of HD Liquid Acids, Diluted Solution for Hemodialysis, Bicarbonate Solution, Peritoneal Dialysis, and Sodium Citrate-primarily for export to the United States and Canada. With over 700 employees, the site also supports Product and Process Development, as well as Sustaining Engineering, contributing to the continuous improvement of our therapies and ensuring high-quality standards across our product portfolio. Join our passionate team and be part of this global impact!.\nAs a Quality System Engineer, you will support Quality Operations by ensuring compliance with quality system, regulatory, and corporate requirements. The role is responsible for reviewing manufacturing and quality records, managing product disposition activities, maintaining quality documentation, supporting batch release processes, and driving continuous improvement initiatives.\nResponsibilities\nReview and disposition finished product and plastic bag batch records.\nMonitor and control finished product lots, including product disposition activities in SAP.\nVerify compliance with parametric release requirements for saline solutions, including export products.\nReview environmental monitoring, water system monitoring, raw material inspection, manufacturing execution, and receiving records.\nReview nonconformances and deviations to ensure quality requirements are met prior to product release or rejection.\nAdminister the containment hold system and support batch release activities.\nMaintain, update, and ensure compliance of Quality System procedures with applicable regulations and corporate requirements.\nOrganize, maintain, and safeguard Quality Technical Archive documentation.\nPrepare and update procedures supporting departmental activities.\nComply with site and corporate procedures, policies, safety regulations, and training requirements.\nParticipate in continuous improvement initiatives within Quality Operations.\nQualifications\nBachelor’s Degree in Chemistry, Pharmaceutical Sciences, Industrial Engineering, Chemical Engineering, or a related field.\n1 year of experience in a similar position.\nKnowledge of Statistical Process Control (SPC).\nKnowledge of ISO 13485, 21 CFR Parts 210, 211, and 820, and NOM-241-SSA1.\nProficiency in Microsoft Office applications.\nKnowledge of Quality Systems.\nKnowledge of SAP or similar ERP systems.\nIntermediate English.\nAdherence to established guidelines and procedures.\nLearning agility and capacity to acquire new knowledge.\nStrong interpersonal skills.\nResults-oriented with a focus on achieving goals.\nProblem-solving skills with the ability to develop alternatives and solutions.\nAbility to work under pressure.\nTeamwork and collaboration to achieve results.\nOur Offer for You\nThere is a lot you can discover at Fresenius Medical Care, regardless of your background or level of experience-all dedicated to your professional journey.\nWhether in front of or behind the scenes, you are helping make ever better medicine available to more people around the world.\nIndividual opportunities for career development and professional growth.\nA culture that encourages innovative thinking and collaboration.\nThe opportunity to work alongside talented and committed professionals.\nThe benefits of a successful global corporation combined with the collegial culture of a medium-sized 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