{"id":3054150,"url":"https://alion.io/job/arthrex-senior-sterilization-specialist","title":"Senior Sterilization Specialist","company":{"id":12664,"name":"Arthrex","domain":"arthrex.com","url":"https://alion.io/company/arthrex","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":{"grade":"A","score":98,"open_postings":12,"ghost_share":0,"stale_share":0.083,"repost_share":0,"time_to_fill_p50_days":23,"computed_at":"2026-10-30T05:48:23Z"}},"role":"MedTech","role_family":"MedTech","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Naples, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":73000,"max_usd":137000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":50},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Sterilization Validation","optional":false},{"name":"ISO 14971","optional":true},{"name":"Microsoft Office","optional":true},{"name":"Minitab","optional":true},{"name":"SolidWorks","optional":true}],"status":"live","first_seen_at":"2026-10-16T02:00:00Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-30T02:17:37Z","board_verified":true,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"description":"Requisition ID:\n66476 \n\nTitle:\nSenior Sterilization Specialist\n\nArthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for Senior Sterilization Specialist for our Global Headquarters in Naples, FL. The Senior Sterilization Specialist is responsible for Arthrex Inc’s Sterilization and end-user reprocessing projects, validations, and monitoring programs in accordance with quality systems requirements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.\nEssential Duties and Responsibilities:\nParticipate in design review meetings and as a key member of product design teams to assess and validate devices for proper sterilization methods, e.g., radiation, ethylene oxide, and end-user reprocessing etc.;\nDirect and maintain global corporate programs for sterilization cycle maintenance and end-user cleaning and sterilization instructions;\nEnsure Arthrex’s corporate sterilization programs are maintained in accordance with all relevant international standards, e.g., ISO 11135, ISO 11137, ISO 17665, etc. as well as domestic and foreign regulatory requirements;\nCoordinate all activities related to validations and/or testing, and directly interact with external and corporate laboratories, and sterilizers personnel to accomplish the assigned tasks;\nPerform documented assessments, and validations as required of product and process changes for impact to sterilization process efficacy;\nAct as lead auditor and/or subject matter expert for quality management system audits of Arthrex’s global supplier base including critical contract manufacturers, sterilization service providers, and laboratories in accordance with applicable standards, e.g., ISO 13485, ISO/IEC 17025, and international regulatory directives;\nSupport manufacturing organizations in defining requirements for and ensuring infrastructure systems are efficacious in controlling and preventing potential contamination from device contacting materials, utilities, environments, etc.;\nEnsure proper maintenance of files demonstrating internal and vendor compliance and performance including authoring and/or reviewing sterilization validations and product assessments into existing cycles, routine product and environment monitoring reports, non-conformances, CAPA’s, etc.;\nMentor teams, share experience, and provide best practices to sterilization / quality staff related to sterilization systems, corporate policy, and regulatory requirement;\nEncourage and foster an environment based upon a foundation of continuous process improvement and industry benchmarking;\nSupport and lead Arthrex’s business and expansion goals;\nMust be able to travel up to 10% of the time.\nEducation and Experience:\nBachelor’s Degree in Biology/Microbiology, Chemistry, or related science field required.\n5 years relevant experience\nKnowledgeable of FDA and ISO guidelines for the sterilization assessment of medical devices required.\nManufacturing process knowledge preferred.\nProject management and communication skills training preferred.\nWorking knowledge of terminal sterilization methods required.\nHands on experience performing laboratory testing activities.\nTest protocol and report writing experience preferred.\nWorking knowledge of device clinical use and associated harms and hazards\nKnowledge of orthopedic surgery principles, theories, and products preferred.\nKnowledge and Skill Requirements/Specialized Courses and/or Training:\nSpecialized training in manufacturing operations, system design and development, terminal sterilization methods, industrial statistics, and technical writing preferred. Experience in project management tools are highly desirable. Experience in working with Medical Device Risk Management (Specifically ISO 14971), CAPA, Complaint Management, and Nonconformance Reporting preferred.\nMachine, Tools, and/or Equipment Skills:\nProficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company). Solidworks, Minitab, and SAP or corporate ERP systems experience desirable.\nReasoning Ability:\nAbility to define problems, identify opportunities, collect data, analyze established facts, draw valid conclusions, and implement change. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.\nMathematical Skills\nAbility to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.\nLanguage and Communication Skills:\nAbility to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.\nPhysical Demands:\nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit, use hands and fingers to handle or feel, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.\nVision Requirements:\nVisual acuity necessary to do the job safely and effectively.\nWork Environment:\nThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nThe area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually low to moderate.\nArthrex Benefits\nMedical, Dental and Vision Insurance\nCompany-Provided Life Insurance\nVoluntary Life Insurance\nFlexible Spending Account (FSA)\nSupplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)\nMatching 401(k) Retirement Plan\nAnnual Bonus\nWellness Incentive Program\nFree Onsite Medical Clinics\nFree Onsite Lunch\nTuition Reimbursement Program\nTrip of a Lifetime\nPaid Parental Leave\nPaid Time Off\nVolunteer PTO\nEmployee Assistance Provider (EAP)\nAll qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.","description_format":"text","description_chars":6858,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Life insurance","Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Surgical Instruments & Devices","Orthopedic & Spine Implants","Medical Education & Training"],"lifecycle":[{"event":"open","at":"2026-10-22T03:06:19Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 19 · green card filings: 2","filings_12m":19,"filings_prev_12m":27,"green_card_filings_12m":2,"median_offered_wage_usd":167500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.856,"p_room":0.9,"age_days":14,"expected_fill_days":23,"reasons":["conf:3","velocity","win:mid","comp:brand"],"computed_at":"2026-10-30T05:48:23Z"},"pay":null,"html_url":"https://alion.io/job/arthrex-senior-sterilization-specialist","json_url":"https://alion.io/job/arthrex-senior-sterilization-specialist.json","meta":{"generated_at":"2026-10-30T09:39:31Z","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":13892,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"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":12664},"rest":"https://alion.io/mcp/rest/get_company?id=12664"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Farthrex-senior-sterilization-specialist"},{"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%2Farthrex-senior-sterilization-specialist"},{"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%2Farthrex-senior-sterilization-specialist"},{"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/arthrex-senior-sterilization-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Farthrex-senior-sterilization-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3054150}},{"tool":"search_jobs","arguments":{"company":"arthrex.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3054150},"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); 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