{"id":3894576,"url":"https://alion.io/job/stryker-staff-quality-engineer-onsite","title":"Staff Quality Engineer (Onsite)","company":{"id":2579,"name":"Stryker","domain":"stryker.com","url":"https://alion.io/company/stryker","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":85,"open_postings":126,"ghost_share":0.008,"stale_share":0.579,"repost_share":0.016,"time_to_fill_p50_days":34,"computed_at":"2026-11-08T05:47:12Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Alajuela, Costa Rica"],"countries":["CR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-11-06T22:41:54Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-08T16:49:58Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Work Flexibility: OnsiteAs a Quality Engineer, you will support Quality Assurance activities within a regulated medical device environment, partnering with Manufacturing, Research & Development, Regulatory, and Engineering teams. You will monitor product and process quality, investigate nonconformances, manage quality data, and support compliance with FDA Quality System requirements, ISO 13485, and the Medical Device Single Audit Program (MDSAP).\nWhat you will do\nInvestigate product and process quality issues with cross-functional teams, performing risk assessments, historical record reviews, nonconformance evaluations, and corrective action activities.\nCoordinate containment and disposition of nonconforming product, including identification, segregation, reconciliation, and documented resolution.\nMonitor and trend quality data to identify potential issues and provide data-based quality insights to management.\nManage Corrective and Preventive Action (CAPA) activities and verify compliance with Quality Management System requirements.\nApply statistical methods to establish sampling plans and evaluate the effectiveness of corrective actions.\nInterpret risk management documentation, including Failure Modes and Effects Analysis (FMEA), to support quality and risk-based decisions.\nSupport internal and external audits, respond to audit findings, and evaluate Quality Management System changes required to maintain regulatory compliance.\nPartner with Quality Assurance, Manufacturing, Engineering, Research & Development, and Regulatory teams to resolve quality issues and escalate risks requiring management review.\nWhat you will need\nRequired\nBachelor’s degree in Engineering or a related technical field.\nMinimum 5 years of Quality Engineering experience.\nProfessional proficiency in English and Spanish, written and verbal.\nWorking knowledge of FDA 21 CFR Part 820, ISO 13485, and MDSAP.\nExperience using Microsoft Word and Excel.\nPreferred\nExperience working in the medical device industry or another regulated manufacturing environment.\nExperience with CAPA, nonconformance management, FMEA, risk management, statistical sampling, and quality audits.\nTravel Percentage: 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