{"id":3403623,"url":"https://alion.io/job/coopercompanies-quality-engineer-ii-sterilization","title":"Quality Engineer II (Sterilization)","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":80,"open_postings":16,"ghost_share":0,"stale_share":0.813,"repost_share":0,"time_to_fill_p50_days":26,"computed_at":"2026-11-02T06:13:15Z"}},"role":"MedTech","role_family":"MedTech","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":["La Garita, Costa Rica"],"countries":["CR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":27000,"max_usd":55000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":52},"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":"Outlook","optional":false},{"name":"Sterilization Validation","optional":false}],"status":"live","first_seen_at":"2026-10-28T15:18:34Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-11-01T21:15:32Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"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 Sterility Assurance & Contamination Control\nSupport and maintain Global Sterility Assurance and Contamination Control programs aligned with all applicable manufacturing sites.\nProvide quality oversight for sterilization processes including Ethylene Oxide (EO), Gamma, Electron Beam, and other applicable sterilization modalities.\nSupport sterilization validation, requalification, and change assessments associated with sterilization processes.\nReview and analyze sterilization data, dose audits, cycle performance, and validation results to ensure continued state of control.\nSupport contamination control strategy development and implementation across manufacturing and controlled environments including media aseptic processing.\nEnvironmental Monitoring\nSupport Environmental Monitoring (EM) programs including viable and non-viable monitoring activities.\nReview environmental monitoring trends and investigate adverse trends, excursions, and action level events.\nPartner with Microbiology and Operations teams to identify and implement corrective actions for contamination-related issues. \nSupport cleanroom qualification and ongoing cleanroom performance monitoring programs.\nInvestigations & Continuous Improvement\nLead and facilitate complex root cause investigations related to contamination events, EM excursions, sterilization failures, process deviations, and product quality issues.\nUtilize structured problem-solving tools such as 5-Why, Fishbone Analysis, Fault Tree Analysis, and statistical methods to identify root causes.\nDevelop and implement effective CAPAs and verify effectiveness of corrective actions.\nTravel:\nThis position may require 10-20% domestic and/or international travel.\n Knowledge, Skills and Abilities:\nWorking knowledge of sterilization standards including ISO 11135, ISO 11137, and applicable sterilization regulations as well as FDA 21 CFR Part 820, ISO 13485, and applicable global regulatory requirements.\nUnderstanding of sterility assurance principles, SAL concepts, microbiological controls, bioburden management, and contamination prevention strategies.\n\nExperience supporting Environmental Monitoring programs in controlled manufacturing environments including aseptic processing.\n\nKnowledge of cleanroom classifications, cleanroom monitoring, and contamination control practices.\n\nAbility to work in a matrixed organization, developing strong relationships with all levels of staff and management, partnering across multidisciplinary teams (internal/external).\nExperience supporting process validation, CAPA, nonconformance management, and change control.\nStrong time management skills to drive multiple projects to completion on time.\nStrong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).\nStrong data analysis, negotiation, and problem-solving skills.\nMust be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.\nExperience in participating in regulatory audits/inspections is preferred.\nProficient in reading, writing, and communicating in the English language. \nWork Environment:\nProduction/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day. \nOccasionally lift to 35 pounds.\nExperience:\n3+ years of experience in medical device, pharmaceutical, biologics, or healthcare industry related experience.\nDemonstrated experience supporting sterilization processes such as Ethylene Oxide (EO), Gamma Irradiation, Electron Beam, X-ray, or equivalent sterilization technologies.\nDemonstrated experience supporting sterilization validations, revalidations, and lifecycle management.\nDemonstrated experience with Environmental Monitoring, cleanroom operations, contamination control, or microbiological quality systems.\nExperience conducting Root Cause Analysis (RCA), implementing effective corrective and preventive actions, including CAPA, investigations, nonconformance management, deviations, and change control activities.\nExperience supporting internal audits, supplier audits, regulatory inspections, and external audits preferred.\nExperience utilizing statistical analysis and trending methodologies to evaluate process and environmental performance data.\nEducation:\nBachelor’s degree in a health, Engineering or Science field is preferred. \nSterilization Association certification or equivalent sterilization training preferred.\n\nASQ or equivalent certification and/or relevant work experience is preferred. Other Professional certification is preferred (i.e. CQE, SQE, etc.)\nTo all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.\nWe are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at ","description_format":"text","description_chars":6531,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Eyewear","Women’s Health & Maternity","Fertility & IVF","Sterilization & Infection Control"],"lifecycle":[{"event":"open","at":"2026-10-28T15:25:45Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":4,"expected_fill_days":26,"reasons":["conf:8","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-02T06:13:15Z"},"pay":null,"html_url":"https://alion.io/job/coopercompanies-quality-engineer-ii-sterilization","json_url":"https://alion.io/job/coopercompanies-quality-engineer-ii-sterilization.json","meta":{"generated_at":"2026-11-02T09:53:42Z","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":13819,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":2859488},"rest":"https://alion.io/mcp/rest/get_company?id=2859488"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcoopercompanies-quality-engineer-ii-sterilization"},{"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%2Fcoopercompanies-quality-engineer-ii-sterilization"},{"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%2Fcoopercompanies-quality-engineer-ii-sterilization"},{"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/coopercompanies-quality-engineer-ii-sterilization\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcoopercompanies-quality-engineer-ii-sterilization"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3403623}},{"tool":"search_jobs","arguments":{"company":"coopercos.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3403623},"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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