{"id":1707077,"url":"https://alion.io/job/teleflex-ingenyx-senior-quality-engineer-sterility-assurance-validation","title":"INGENYX- Senior Quality Engineer - Sterility Assurance & Validation","company":{"id":1764434,"name":"Teleflex","domain":"teleflex.com","url":"https://alion.io/company/teleflex","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"MedTech","role_family":"MedTech","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":115500,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Sterilization Validation","optional":false}],"status":"live","first_seen_at":"2026-09-29T07:00:00Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-11-02T07:22:15Z","board_verified":true,"closed_at":null,"days_open":34,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":34},"description":"Expected Travel: Up to 50%\nRequisition ID: 14320\nIngenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026.\nIngenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.\nFor more information, please visit Ingenyx.com\nPosition Summary\nWe are seeking an experienced Senior Quality Engineer - Sterility Assurance & Validation to serve as the internal technical owner for sterilization and sterility assurance activities while also supporting broader Quality Engineering and process validation needs.\nThis is a hands-on technical role with responsibility for maintaining validated sterilization processes, providing oversight of contract sterilization providers, supporting microbiological control activities, and ensuring continued compliance with applicable regulatory and quality system requirements.\nThe ideal candidate brings strong medical device Quality Engineering experience with demonstrated expertise in EO and radiation sterilization, process validation, and sterility assurance.\nPrincipal Responsibilities\nSterility Assurance & Sterilization\nServe as the internal technical owner for the Sterility Assurance program.\nProvide technical oversight of ethylene oxide (EO) and radiation sterilization processes.\nSupport sterilization cycle transfer, validation, requalification, and maintenance of the validated state.\nReview and approve sterilization qualification and requalification protocols and reports.\nReview sterilization cycle deviations, excursions, nonconformances, and change assessments.\nSupport investigation, root cause analysis, CAPA, and risk assessment for sterilization-related issues.\nCoordinate and review annual Sterility Assurance and bioburden technical assessments.\nProvide oversight of radiation dose audits, including review of Quarterly Dose Audit results, as applicable.\nMonitor bioburden data and trends and coordinate specialized microbiology support when required.\nProvide technical oversight of contract sterilizers and support supplier qualification, audits, SCARs, and quality agreements.\nMaintain sterilization procedures, technical documentation, validation records, and required periodic reviews.\nSupport regulatory inspections, certification audits, customer audits, and technical inquiries related to sterilization and sterility assurance.\nPartner with external microbiology laboratories and specialized Sterilization/Microbiology SMEs as required.\nQuality Engineering & Validation\nSupport manufacturing process validation activities, including IQ, OQ, and PQ.\nProvide Quality Engineering support for manufacturing processes, process changes, equipment qualification, and technology transfers.\nReview and approve validation protocols, reports, engineering studies, and associated quality records.\nSupport nonconformance investigations, deviations, CAPAs, and root cause analysis.\nParticipate in manufacturing and process risk management activities, including PFMEAs and change assessments.\nApply appropriate statistical techniques to validation, process monitoring, and problem-solving activities.\nPartner with Operations, Engineering, Supplier Quality, Regulatory Affairs, and other Quality functions to maintain compliant and capable manufacturing processes.\nSupport continuous improvement and risk-reduction initiatives.\nEducation / Experience Requirements\nBachelor's degree in Engineering, Life Sciences, Microbiology, or a related technical discipline.\n7+ years of Quality Engineering, Validation, Sterility Assurance, or related experience within the medical device industry.\nDemonstrated experience with medical device sterilization processes, preferably including EO and radiation sterilization.\nStrong experience with process validation and maintenance of validated processes.\nWorking knowledge of:\no ISO 11135 - Ethylene oxide sterilization\no ISO 11137 - Radiation sterilization\no ISO 11737 - Bioburden and sterility testing\no ISO 13485\no FDA medical device Quality System requirements\nExperience investigating sterilization deviations, process excursions, nonconformances, and CAPAs.\nExperience working with contract sterilization providers and/or external testing laboratories.\nAbility to independently assess technical information, make risk-based recommendations, and clearly document conclusions.\nStrong cross-functional communication and technical writing skills.\nSpecialized Skills / Other Requirements\nExperience with both EO and gamma radiation sterilization.\nExperience with sterilization cycle transfer, duplication, or establishment of new sterilization cycles.\nExperience with bioburden trending and microbiological control programs.\nExperience with radiation dose audits and dose-maintenance programs.\nExperience supporting regulatory or Notified Body audits involving sterilization.\nExperience in contract manufacturing or multi-site medical device environment.\nASQ CQE or other relevant Quality/Validation certification, preferred.\nWhat Success Looks Like\nThe successful candidate will establish strong internal ownership of Sterility Assurance while effectively leveraging external laboratories and specialized SMEs when deeper expertise is required. This role will ensure that sterilization processes remain validated and compliant while also providing hands-on Quality Engineering and Validation support to the broader manufacturing organization.\nThis position is well suited for an experienced Quality Engineer who wants to become a key technical leader in Sterility Assurance without moving away from hands-on engineering and problem solving.\nThe pay range for this position at commencement of employment is expected to be between $115,500- $140,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.\nIf hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.\nAt Ingenyx, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.\nIngenyx is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or .","description_format":"text","description_chars":7927,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Parental leave","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-02T15:13:22Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2","filings_12m":2,"filings_prev_12m":6,"green_card_filings_12m":0,"median_offered_wage_usd":72500,"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":38,"band":"fade","label":"Fading","p_open":1,"p_active":0.686,"p_room":0.55,"age_days":33,"expected_fill_days":28,"reasons":["conf:3","win:tail","comp:brand"],"computed_at":"2026-11-02T06:13:15Z"},"pay":{"stated_usd_annual":140000,"is_top_pay":false},"html_url":"https://alion.io/job/teleflex-ingenyx-senior-quality-engineer-sterility-assurance-validation","json_url":"https://alion.io/job/teleflex-ingenyx-senior-quality-engineer-sterility-assurance-validation.json","meta":{"generated_at":"2026-11-02T10:00:43Z","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":14021,"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":1764434},"rest":"https://alion.io/mcp/rest/get_company?id=1764434"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fteleflex-ingenyx-senior-quality-engineer-sterility-assurance-validation"},{"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%2Fteleflex-ingenyx-senior-quality-engineer-sterility-assurance-validation"},{"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%2Fteleflex-ingenyx-senior-quality-engineer-sterility-assurance-validation"},{"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/teleflex-ingenyx-senior-quality-engineer-sterility-assurance-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fteleflex-ingenyx-senior-quality-engineer-sterility-assurance-validation"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1707077}},{"tool":"search_jobs","arguments":{"company":"teleflex.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1707077},"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. Docs: https://alion.io/developers"}}