{"id":1707150,"url":"https://alion.io/job/teleflex-ingenyx-quality-engineer-3","title":"INGENYX - Quality Engineer 3","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":"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":"inferred","locations":["Trenton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":86000,"max_usd":158000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3690},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-16T00:00:00Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-10-13T10:07:41Z","board_verified":false,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"Expected Travel: Up to 10%\nRequisition ID: 14411\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\nThe Quality Engineer 3 provides Quality Engineering leadership and support to manufacturing as a lead Quality team member. Key areas of responsibility include:\nNonconformance (NC) and CAPA coordination and processing\nCustomer complaint investigations\nProcess and product validations\nCustomer change-notification evaluations\nInternal and external audit support\nQuality improvement initiatives\nCompliance with Ingenyx and local procedures and policies\nPrincipal Responsibilities\nNonconformance (NC) & CAPA - Lead Quality activities for Conductor Material Review Board coordination, inspection methods, NC containment/correction/closure, and CAPAs. Analyze trend data and drive improvements.\nCustomer Complaint Investigations - Lead Conductor complaint investigations, confirmation, and corrective actions. Serve as the primary customer contact for complaint communications and drive improvements based on trends.\nProcess Validations - Guide and review protocol development, validation execution, and final reports for acceptance.\nQuality & Cost Improvement - Lead and participate in short-term product and process improvement projects.\nProduction & Process Controls - Review, revise, and approve Manufacturing Procedures, Test Method validations, Quality Inspection Plans, and process run sheets.\nAuditing - Perform internal and process audits; participate in vendor audits as needed; and support Back Room activities during FDA and Notified Body audits.\nDocumentation Control - Review Customer Product Specifications. Initiate Engineering Change Notices and review/approve changes as needed.\nTraining - Conduct QA training certifications for new Production operators.\nEngineering Support - Support product improvements through quality planning, risk evaluation, and validation.\nOther Duties - Perform additional QA responsibilities as assigned by the QA Manager.\nEducation / Experience Requirements\nBachelor’s degree preferred, or equivalent ASQ Certified Quality Engineer certification. Strong communication and presentation skills required.\n3+ years of Quality Assurance experience required.\nManufacturing experience required; regulated or medical industry experience preferred.\nDemonstrated experience or success in the following areas:\nCAPA and Nonconformance processes\nCustomer complaint investigations\nValidation concepts and techniques (process, equipment, and test methods)\nContinuous improvement and project management\nProcess and/or internal auditing\nSpecialized Skills / Other Requirements\nKnowledge of QSR, CFR, cGMP, and ISO regulations required.\nProficiency with Microsoft Word, Excel, and PowerPoint required.\nExperience with Minitab and SAP ERP preferred.\nKnowledge of statistical techniques preferred (DOE, SPC, Gage R&R).\nStrong problem-solving skills and experience with Root Cause Analysis tools (6M, Cause-and-Effect, 5 Whys, etc.).\nStrong verbal, written, and listening skills.\nStrong interpersonal skills and ability to work effectively in a team environment.\nAbility to prioritize and adapt to changing priorities.\nAbility to work independently with limited supervision.\nASQ Certified Quality Auditor highly preferred.\nDesign Control and Risk Management experience preferred.\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":4804,"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":[]},"benefits":[],"hiring_locations":[],"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":"2026-10-15T11:24:14+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":28,"band":"fade","label":"Fading","p_open":1,"p_active":0.624,"p_room":0.45,"age_days":29,"expected_fill_days":18,"reasons":["conf:43","velocity","win:tail","comp:brand"],"computed_at":"2026-10-15T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/teleflex-ingenyx-quality-engineer-3","json_url":"https://alion.io/job/teleflex-ingenyx-quality-engineer-3.json","meta":{"generated_at":"2026-10-15T18:08:44Z","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":27523,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-16T00:00:00Z"}},"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-quality-engineer-3"},{"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-quality-engineer-3"},{"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-quality-engineer-3"},{"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-quality-engineer-3\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fteleflex-ingenyx-quality-engineer-3"}]}