{"id":3098571,"url":"https://alion.io/job/baxter-quality-engineer-ii","title":"Quality Engineer II","company":{"id":5835,"name":"Baxter","domain":"baxter.com","url":"https://alion.io/company/baxter","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":84,"open_postings":12,"ghost_share":0,"stale_share":0.833,"repost_share":0,"time_to_fill_p50_days":13,"computed_at":"2026-10-28T05:59:10Z"}},"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":["Cartago, Costa Rica"],"countries":["CR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":25000,"max_usd":55000,"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":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Microsoft Excel","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-22T16:54:47Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-28T10:43:40Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"This is where your work makes a difference.\nAt Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.\nOur Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.\nHere, you will find more than just a job-you will find purpose and pride.\nYour role at Baxter:\nResponsible for managing, maintaining and improving the Quality Management System processes, including CAPA, Internal and External Audits, Non-Compliant Product, Document Control, Quality Release, CAPA Board and Management Review, ensuring compliance with applicable regulatory, corporate and normative requirements.\nWill lead initiatives for continuous improvement, trend analysis and management of quality indicators to ensure the effectiveness of the Quality System and the fulfillment of business objectives. In addition, he supervises and develops the personnel assigned to the Quality Systems area, promoting a culture of quality, compliance and operational excellence.\nIdentifies and evaluates gaps and systemic risks of the Quality System and leads Quality Plans and cross-functional remediation plans until their closure, effectiveness and sustainability are demonstrated. Applies knowledge of Quality Risk Management, Change Control and validation principles to evaluate impact and coordinate technical actions with Process Owners and Subject Matter Experts.\nWhat you will be doing:\nManage the CAPA system, ensuring effective investigations, root cause analysis, implementation of corrective and preventive actions, and verification of effectiveness.\nCoordinate and facilitate CAPA Board meetings, providing metrics, trend analysis, and action tracking.\nManage the Non-Conforming Product system, ensuring the proper containment, investigation, disposition and monitoring of non-conforming materials or products.\nPlan, coordinate and execute the risk-based Internal Audit program.\nCoordinate the preparation and execution of external audits, certifications and regulatory inspections.\nEnsure the timely implementation and closure of corrective actions derived from internal, external and regulatory audits.\nCoordinate the Management Review process, preparing indicators, trends, metrics and reports for senior management.\nManage the Document Control system, ensuring the creation, review, approval, distribution, and maintenance of controlled documents.\nOversee the Quality Release process, ensuring that products meet all quality and regulatory requirements prior to release.\nMonitor key indicators of the Quality System, identify risks and opportunities for improvement and implement action plans.\nMaintain updated procedures, policies and records associated with the Quality Management System.\nManage the CAPA system, ensuring effective investigations, root cause analysis, implementation of corrective and preventive actions, and verification of effectiveness.\nCoordinate and facilitate CAPA Board meetings, providing metrics, trend analysis, and action tracking.\nManage the Non-Conforming Product system, ensuring the proper containment, investigation, disposition and monitoring of non-conforming materials or products.\nPlan, coordinate and execute the risk-based Internal Audit program.\nCoordinate the preparation and execution of external audits, certifications and regulatory inspections.\nEnsure the timely implementation and closure of corrective actions derived from internal, external and regulatory audits.\nCoordinate the Management Review process, preparing indicators, trends, metrics and reports for senior management.\nManage the Document Control system, ensuring the creation, review, approval, distribution, and maintenance of controlled documents.\nOversee the Quality Release process, ensuring that products meet all quality and regulatory requirements prior to release.\nMonitor key indicators of the Quality System, identify risks and opportunities for improvement and implement action plans.\nMaintain updated procedures, policies and records associated with the Quality Management System.\nWhat will you bring?\nUniversity Baccalaureate in Industrial Engineering, Chemistry, or related career.\nMinimum 3 years of experience in manufacturing, Quality Systems and Compliance.\nExperience in CAPA, audits, document control, non-conforming product and Quality Release.\nAdvanced English (oral and written).\nKnowledge of regulations and quality management systems applicable to the industry.\nKnowledge of Quality Management Systems and applicable regulatory requirements.\nKnowledge of ISO 13485, ISO 9001, MDSAP, 21 CFR Part 820 and GMPs.\nExperience in CAPA, Audits, Non-Conforming Product, Document Control and Quality Release.\nKnowledge of root cause analysis and troubleshooting methodologies (5 Why, Fishbone, 8D, DMAIC).\nExperience in indicator management, trend analysis and risk assessment.\nProficiency in Microsoft Office, especially advanced Excel.\nKnowledge of Artificial Intelligence tools applied to data analysis, process automation and continuous improvement\nKnowledge in Validations and Risk management\nEqual Employment Opportunity\nBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.\nReasonable Accommodations\nBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.\nRecruitment Fraud Notice\nBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.","description_format":"text","description_chars":6589,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Patient Monitoring","Hospital Equipment & Furniture","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-10-22T16:54:47Z"}],"visa":[],"liveness":{"score":56,"band":"ok","label":"Likely open","p_open":1,"p_active":0.622,"p_room":0.9,"age_days":5,"expected_fill_days":13,"reasons":["conf:0","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/baxter-quality-engineer-ii","json_url":"https://alion.io/job/baxter-quality-engineer-ii.json","meta":{"generated_at":"2026-10-28T12:22:35Z","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":"search","counted_by":"address","units_charged":0,"used_today":0,"day_limit":null,"remaining_today":null,"minute_limit":null,"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":5835},"rest":"https://alion.io/mcp/rest/get_company?id=5835"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbaxter-quality-engineer-ii"},{"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%2Fbaxter-quality-engineer-ii"},{"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%2Fbaxter-quality-engineer-ii"},{"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/baxter-quality-engineer-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbaxter-quality-engineer-ii"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3098571}},{"tool":"search_jobs","arguments":{"company":"baxter.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3098571},"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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