{"id":2876360,"url":"https://alion.io/job/teleflex-ingenyx-quality-systems-and-digital-engineer","title":"INGENYX - Quality Systems and Digital Engineer","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":"QA","role_family":"QA","seniority":"middle","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":{"label":"CT","utc_offset_min":-6,"utc_offset_max":-6},"hiring_geo_confidence":"explicit","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":87400,"max":109200,"currency":"USD","period":"year","gross":null,"usd_annual":109200},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-10-19T21:35:53Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-28T00:00:43Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"Expected Travel: None\nRequisition ID: 14577\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 a Quality Systems & Digital Quality Engineer to support the digital transformation, validation, administration, and continuous improvement of Quality Management System (QMS) technologies and applications across a global medical device organization.\nReporting to the Quality Systems Manager, this role serves as the Quality functional and technical liaison between Quality process owners, IT, business stakeholders, and software vendors. The position is responsible for Computer System Validation/Computer Software Assurance (CSV/CSA), digital Quality workflows, Quality data and analytics, and ongoing lifecycle management of computerized Quality systems.\nThe role will help ensure Quality applications are compliant, effective, appropriately validated, and designed to support efficient and standardized Quality processes.\n**Candidates must be based remotely in the US, with a strong preference for Eastern and Central Time Zones**\nPrincipal Responsibilities\nCSV / Computer Software Assurance - Approximately 30%\nOwn CSV/CSA activities for eQMS platforms, ERP Quality functionality, and other computerized applications supporting Quality processes.\nDevelop risk-based validation strategies appropriate to the system's intended use, functionality, and potential impact on product quality and patient safety.\nDevelop, review, and maintain validation documentation, including requirements, risk assessments, validation plans, test protocols/scripts, traceability, deviations, and validation summary documentation.\nCoordinate and execute testing for new systems, configurations, integrations, enhancements, upgrades, and significant changes.\nEnsure business and Quality requirements are appropriately traced to testing and release documentation.\nAssess computerized system changes for validation impact and determine appropriate testing and documentation requirements.\nMaintain systems in a validated state throughout their lifecycle.\nSupport investigation and resolution of validation deviations and system-related quality issues.\nApply risk-based CSA principles to streamline validation activities while maintaining appropriate compliance and objective evidence.\nSupport audit and regulatory inspection readiness for computerized system validation records.\nQMS Technology & Digitalization - Approximately 30%\nServe as a Quality functional SME and super-user for eQMS, ERP Quality modules, and other Quality applications.\nPartner with Quality process owners to translate business and regulatory requirements into effective digital workflows and system requirements.\nSupport configuration, implementation, testing, deployment, and enhancement of Quality system functionality.\nIdentify opportunities to simplify, standardize, and automate Quality processes.\nSupport conversion of manual, paper-based, or spreadsheet-driven Quality processes into controlled electronic workflows.\nDevelop process maps, functional requirements, user requirements, and workflow designs for Quality applications.\nSupport integration between Quality applications and ERP, document management, training, manufacturing, supplier, and other business systems.\nPartner with IT and software vendors to troubleshoot system issues and coordinate enhancements.\nSupport user acceptance testing and deployment of new or revised functionality.\nDevelop and maintain user guides, work instructions, and system/process documentation.\nSupport training and adoption of new digital Quality processes and tools.\nQuality Data & Analytics - Approximately 20%\nDevelop and maintain Quality metrics, dashboards, and reporting tools.\nAnalyze Quality data to identify trends, risks, recurring issues, and improvement opportunities.\nSupport reporting and trending for CAPA, nonconformance, complaints, audits, suppliers, inspection, training, and other Quality processes.\nPartner with process owners to establish meaningful KPIs and measures of process effectiveness.\nImprove standardization, consistency, and integrity of Quality data across systems.\nIdentify opportunities to automate recurring Quality reports and reduce manual data manipulation.\nSupport Quality Management Review and leadership reporting.\nPerform data analysis to support continuous improvement, CAPA, project activities, and Quality objectives.\nSupport development of data visualization and reporting capabilities that enable timely, risk-based decision-making.\nPrincipal Responsibilities Continued\nSystem Lifecycle & Continuous Improvement - Approximately 20%\nMaintain or support the inventory of computerized systems used within the Quality organization.\nMaintain system information, including intended use, ownership, Quality/regulatory impact, validation status, interfaces, and lifecycle status.\nCoordinate periodic reviews of validated Quality systems.\nSupport system and change impact assessments.\nSupport Quality aspects of user access, roles, permissions, and periodic access reviews in partnership with IT and system owners.\nSupport vendor assessments and ongoing oversight of third-party Quality system providers.\nSupport data migration, system upgrades, system retirement, archival, and record retention activities.\nMonitor system performance and identify opportunities for improved usability, efficiency, compliance, and standardization.\nSupport investigation and remediation of system-related audit findings, data integrity concerns, and compliance gaps.\nPromote standardized digital Quality processes and sharing of best practices across sites and functions.\nCompliance & Governance\nSupport compliance with applicable Quality System, electronic record, electronic signature, and computerized system requirements.\nSupport compliance with 21 CFR Part 11, FDA QMSR, ISO 13485, and applicable internal procedures.\nApply data integrity principles throughout the computerized system lifecycle.\nMaintain validation and system lifecycle documentation in an audit- and inspection-ready state.\nSupport internal audits, customer audits, and regulatory inspections involving Quality computerized systems.\nPartner with Quality Systems, IT, and process owners to maintain appropriate controls for electronic records, electronic signatures, audit trails, security, access, backup, recovery, and data retention.\nSupport development and continuous improvement of CSV/CSA, digital Quality, data governance, and system lifecycle procedures and practices.\nEducation / Experience Requirements\nRequired\nBachelor’s degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, Data Analytics, or a related technical discipline.\n3+ years of experience in Quality Systems, Quality Engineering, computerized system validation, digital Quality, business systems, or a related function within a regulated industry.\nWorking knowledge of 21 CFR Part 11, FDA QMSR, and ISO 13485.\nFamiliarity with Computer Software Assurance (CSA), CSV, GAMP 5, and risk-based validation principles.\nExperience supporting computerized systems within a Quality or regulated environment.\nExperience with system requirements, testing, validation, change control, or system implementation.\nWorking knowledge of Quality Management Systems and regulated business processes.\nStrong analytical skills with experience analyzing and presenting Quality or operational data.\nAbility to translate business and Quality requirements into system requirements and practical solutions.\nStrong technical writing, documentation, problem-solving, and organizational skills.\nAbility to work effectively across Quality, IT, Operations, business functions, and external vendors.\nPreferred\nMedical device industry experience.\nExperience with eQMS and/or ERP Quality functionality.\nExperience with CAPA, nonconformance, document control, training, audit, supplier quality, complaint, or change management applications.\nExperience developing Quality dashboards, metrics, automated reporting, or data visualization.\nExperience with cloud/SaaS applications and vendor-managed systems.\nFamiliarity with data integrity, electronic records, electronic signatures, audit trails, and computerized system lifecycle management.\nExperience supporting regulatory inspections or customer audits involving computerized systems.\nSpecialized Skills / Other Requirements\n#LI-AD1\nThe pay range for this position at the commencement of employment is expected to be between $87,400 and $109,200; however, the 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, the 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":10915,"description_truncated":false,"requirements":{"experience_years_min":3,"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":["Surgical Instruments & Devices","Cardiovascular Devices","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-19T21:35:53Z"}],"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":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":7,"expected_fill_days":24,"reasons":["conf:3","win:early","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":109200,"is_top_pay":true},"html_url":"https://alion.io/job/teleflex-ingenyx-quality-systems-and-digital-engineer","json_url":"https://alion.io/job/teleflex-ingenyx-quality-systems-and-digital-engineer.json","meta":{"generated_at":"2026-10-28T04:48:24Z","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":6226,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"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-systems-and-digital-engineer"},{"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-systems-and-digital-engineer"},{"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-systems-and-digital-engineer"},{"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-systems-and-digital-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fteleflex-ingenyx-quality-systems-and-digital-engineer"}]}