{"id":4020578,"url":"https://alion.io/job/teleflex-ingenyx-quality-engineering-technician-2","title":"INGENYX- Quality Engineering Technician","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":"Field & Service","role_family":"Field & Service","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mansfield, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Power BI","optional":false},{"name":"Python","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-11-10T14:54:49Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-11T02:46:50Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Expected Travel: Up to 10%\nRequisition ID: 14708\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\nQuality Engineering Technician is a hands-on engineering support role responsible for planning and executing process monitoring, equipment oversight, validation activities, and continuous improvement initiatives with guidance from Quality Engineering. This position works closely with Manufacturing, Operations, Engineering, and Quality teams to drive process robustness, improve product quality, reduce variation, and ensure compliance with applicable quality system and regulatory requirements.\nThe ideal candidate is capable of decisive, swift and precise execution of change with an eye for detail & improvement and brings with them an enthusiastic demeanor.\nPrincipal Responsibilities\nProvide day-to-day quality support for engineering operations. Track and communicate project status.\nAssist in quality engineering tasks, such as: data analysis, investigations into potential non-conformance or complaints, or validation activities (TMV, IQ/OQ/PQ).\nAuthor or co-author engineering, validation, and/or qualification protocols and reports.\nQuality support functions include execution or preparation of quality plans, documentation retrieval during audits, qualification/validation protocols and reports, routing/review/revision of documentation as needed.\nSupport manufacturing by reviewing production documentation for completeness and correctness.\nSubmit or fulfill engineering change orders, including process change or improvement activities.\nAcquire and analyze manufacturing and quality data to identify trends, risks, and improvement opportunities.\nAssist in technical root cause investigations related to manufacturing processes, equipment performance, and product quality issues.\nAssist in maintenance of the calibration program, including investigation of calibration abnormalities or filing of metrological paperwork.\nCollaborate with Manufacturing Engineering on equipment, tooling, automation, and process improvement projects.\nParticipate in risk assessments and implementation of risk mitigation activities.\nSupport transfer of new products and processes into manufacturing.\nParticipate in and propose operational excellence activities to reduce scrap, enhance efficiency, and improve quality.\nEnsure compliance with applicable company procedures, FDA regulations, ISO 13485 requirements, and customer expectations.\nUpdates procedures, work instructions, or other documentation, and leads change orders to execute updates as needed.\nEducation / Experience Requirements\nAssociate’s or Bachelor's Degree in Engineering, or related technical discipline.\nMinimum 1 year of quality or manufacturing experience in a regulated environment.\nPreferred: Experience supporting manufacturing, calibration, or qualify systems.\nPreferred: Experience in medical device manufacturing.\nPreferred: Experience with data analysis, non-conformance investigation, and authoring of protocols and reports.\nSpecialized Skills / Other Requirements\nKnowledge of root cause analysis tools and problem-solving methodologies.\nKnowledge of FDA QMSR, ISO 13485, and cGMP requirements.\nAbility to work effectively in cross-functional teams and communicate technical information clearly.\nStrong organizational, analytical, and problem-solving skills.\nProficiency in Microsoft Office applications and data analysis tools, such as Power BI, QI Macros, Excel (advanced), Python, or R.\nPreferred: Understanding of SPC, process capability studies, and data analysis techniques.\nPreferred: Experience with handling non-conformances.\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. 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