Quality Engineer 2, Product Quality Assurance

Quality Engineer 2, Product Quality Assurance Date: Dec 2, 2025 Location: Chelmsford, MA, US Company: Teleflex Expected Travel: Up to 10% Requisition ID: 13110 Position Summary Supports the Product Quality Assurance team analyzing post-market data and potential product quality issues for commercialized devices. Accountable for a broad range of technical assignments in the Quality Assurance area under general supervision and working with cross‑functional investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ISO 13485 and ISO 14971. Principal Responsibilities Create, investigate, and/or manage nonconformances, as well as associated ship holds and product disposition Investigate, compile, and report on information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products are warranted Work closely with Manufacturing sites, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory to investigate and document quality issues Assist with compilation and analysis of product quality metrics for presentation to Global and business unit leadership Utilize statistical techniques to identify rates, changes in trends, or estimated occurrences based on bench and field data Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to respond to Product Quality issues Assist during regulatory inspections and/or audits and present as required Utilize SAP, Agile, and other systems as warranted for data input and quality record maintenance Communicate and escalate Quality issues appropriately to QA Manager and address other items as assigned by Manager Education / Experience Requirements BS Degree in Engineering (or related technical field) 2–5 years related (medical device preferred) experience Experience with statistical analysis using Minitab and/or Microsoft Excel Quality Assurance (21CFR820, ISO13485) and Risk Management (ISO 14971) experience desired Experience with Corrective Action and Nonconformance process Specialized Skills / Other Requirements Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required Experience with Corrective Action, Manufacturing and Design Control concepts desired Computer literate (statistical software and analysis, Excel, word processing for report generation, PowerPoint presentations, etc.) Positive attitude and ability to operate and communicate effectively with multiple teams & leadership Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems/conflicts, and proactively effect change Compensation & Benefits Pay range: $82,600 – $123,900. Base pay may vary based on location, skills, and experience. Compensation also includes medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and paid time off benefits (PTO, short- and long-term disability, parental leave, dependent on the position offered). Employment Terms At-hire, this is an at-will position. Teleflex reserves the right to modify base salary and other discretionary compensation at any time, including for reasons related to individual performance, company, or market factors. Equal Opportunity Employer Statement Teleflex 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 View phone number on click.appcast.io or View email address on click.appcast.io. Trademarks Teleflex, 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. Copyright © 2025 Teleflex Incorporated. All rights reserved. #J-18808-Ljbffr 6AM City, LLC