{"id":1703057,"url":"https://alion.io/job/coopercos-quality-engineer-temp","title":"Quality Engineer - Temp","company":{"id":2859488,"name":"CooperCompanies","domain":"coopercos.com","url":"https://alion.io/company/coopercos","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":75,"open_postings":13,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-03T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Costa Rica"],"countries":["CR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":23000,"max_usd":50000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":2457},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-01T22:37:37Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-04T00:38:06Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people experience life’s beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.\n Follow and ensure that all personnel comply with FDA regulations, ISO standards, customer requirements, and SOPs as defined by CooperSurgical policies and procedures.\nRepresent Quality in signing on Change Orders.\nManage all Quality responsibilities for assigned manufacturing changes and transfer of new product launches.\nPerform process improvement recommendations and identify opportunities to improve processes, procedures, and systems to increase quality compliance.\nParticipate in validation activities, including but not limited to drafting and/or reviewing protocols and reports; qualify/validate production processes for Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).\nEnsure that all documentation is completed in a timely manner and follows established policies, practices, and procedures.\nInvestigate customer complaints, including root-cause analysis; develop and implement corrective action plans.\nEnsure that the disposition of non-conforming materials meets all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.\nEffectively communicate and interact in a matrix environment.\nParticipate in CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.\nSupport all internal and external audits.\nTrain Quality and Manufacturing personnel on specifications, inspection and testing activities, new product audits, and environmental controls to ensure understanding and compliance; request training, provide training support, and/or coordinate re-training as needed.\n Bachelor’s degree in Engineering required.\nExperience in medical device manufacturing.\n3+ years of work experience in a Quality Engineering role or equivalent.\nWorking knowledge of regulated environments (ISO 13485, 21 CFR 820, and/or other regulations).\nRoot Cause Analysis (CAPA/NCR) experience.\nExperience in planning Process Validation, IQ/OQ/PQ/MSA (software qualification a plus).\nKnowledge of statistical analysis of data and related tools.\nAdvanced computer capabilities including Microsoft Office software.\nStrong interpersonal, written, and oral communication skills in both English and Spanish.\nAbility to read and interpret blueprints and familiarity with Geometric Dimensioning & Tolerancing (GD&T) procedures and requirements.\nCooperSurgical does not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic characteristic, or other characteristics protected by law. 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