{"id":2940812,"url":"https://alion.io/job/teleflex-quality-engineer-3-design-assurance","title":"Quality Engineer 3, Design Assurance","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":"structured","locations":["Maple Grove, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":100500,"max":150800,"currency":"USD","period":"year","gross":null,"usd_annual":150800},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Minitab","optional":false}],"status":"live","first_seen_at":"2026-10-20T17:15:20Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-24T21:19:13Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Expected Travel: Up to 10%\nRequisition ID: 14569\nAbout Teleflex Incorporated\nAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.\nTeleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ - trusted brands united by a common sense of purpose.\nAt Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.\nGlobal Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.\nPosition Summary\nAs a member of a cross-functional team, the Quality Engineer III, Design Assurance is responsible for quality throughout new product development and improvement up to and including technology transfer and commercialization. The Quality Engineer III, Design Assurance ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Quality Engineer III, Design Assurance applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization.\nPrincipal Responsibilities\nPartner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.\nCreate and maintain risk files consisting of but not limited to risk management plans, hazard and risk analyses, failure mode and effects analyses and risk management reports to assess the risks associated with a product.\nAnalyze post-market surveillance data periodically throughout a product’s lifecycle to feed back into it’s risk file in order to reflect it's current risk profile. Support Clinical and Medical Writers in the analysis of available clinical data, as required.\nUse appropriate quality tools and statistical techniques to collect and summarize data, draw conclusions with confidence, determine sample sizes, apply data distributions, identify relationships between variables, calculate reliability, design and analyze experiments, determine process and performance capability, and make statistically supported decisions.\nApply the most relevant and useful quality philosophies throughout Design Control and its related processes for both new product development and sustaining. Understand and manage work to minimize cost of quality throughout the product’s lifecycle.\nEnsure compliance of all practices to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.\nInterpret customer feedback to define user needs and product requirements as part of a cross-functional team.\nPartner with Product Quality Assurance and Operations to make risk-based decisions associated with nonconformances and technical complaints.\nUnderstand applicable external regulations and internal standards that drive compliance and apply them in their daily function. Perform audits of Design History Files and support both internal and external audits.\nPartner with Human Factors SMEs and R&D to assess the usability of a device throughout design and development.\nSupport development and validation of test methods. Identify and apply metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conduct measurement system error studies such as Gage R&R.\nPerform root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities. Accountable for CAPA requirements, timeliness, and effectiveness; present phase status (progress, risks, escalations, and resource needs) at CRB/ECRB meetings; review and disposition CAPA phase, extension, and support technical reviews as needed.\nSupport Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.\nDefine, identify, and apply product and process control methods such as developing control plans, identifying essential design outputs and critical control points, and developing and validating work instructions.\nApply the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interpret and select variable, attribute, and zero-defect sampling plans.\nApply supplier management principles and provide input on projects for supplier selection, quality expectation letters, supplier quality agreements, and process qualifications.\nPartner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.\nContribute to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas related to those identified in this position description.\nGenerally apply the above concepts as required at the local, regional, and departmental level.\nEducation / Experience Requirements\nB.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered)\nMinimum 3 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry).\nSpecialized Skills / Other Requirements\nASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB).\nStrong understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.\nProficient in MS Office, and Minitab or other statistical software.\nStrong organizational and time management skills to meet deadlines while managing multiple projects.\nStrong analytical and critical thinking skills.\nProficient in technical report writing and review.\nStrong verbal and written communication skills.\nFoster a positive culture of growth, collaboration, and achievement across the organization.\nThe pay range for this position at the commencement of employment is expected to be between $100,500.00 and $150,800.00; 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 a 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 Teleflex, 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.\nTeleflex Incorporated 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 .\nTeleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.\n© 2026 Teleflex Incorporated. 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