Quality Engineer II

Quality Engineer II

Date : Nov 6, 2025

Location : Chelmsford, MA, US

Company : Teleflex

Expected Travel : Up to 10%

Requisition ID : 12983

About Teleflex Incorporated

As 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.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com .

Global 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.

Position Summary

The Quality Engineer 2, Manufacturing independently executes quality engineering activities that support the development and maintenance of compliant manufacturing processes. This role contributes to product and process quality throughout the product lifecycle, with emphasis on process validation, test method validation, regulatory compliance, and quality system support. The QE2 works collaboratively with manufacturing, engineering, and cross-functional partners to implement quality initiatives that promote consistent process execution, operational efficiency, and product reliability. The QE2 applies working knowledge of quality systems and industry regulations to support manufacturing readiness, risk-based decision making, and continuous improvement.

Principal Responsibilities

• Independently review and approve quality records, change controls, and production documentation to ensure compliance with internal procedures and regulatory standards.
• Lead the execution of validation activities (IQ / OQ / PQ), test method validation (TMV), and Gage R&R studies by ensuring adherence to protocols and proper data collection.
• Use statistical tools (e.g., control charts, capability analysis, t-tests) to analyze process data and support decision-making related to process capability and improvement.
• Lead risk assessments and drive PFMEA development or updates in coordination with engineering, manufacturing, and regulatory teams.
• Own nonconformance investigations, perform root cause analysis, and support timely and effective CAPA development and closure.
• Author or revise inspection plans, manufacturing procedures, and test methods to ensure appropriate inspection coverage and risk mitigation.
• Support and represent the quality function during internal audits and regulatory inspections by demonstrating compliance with documented processes.
• Independently execute sampling plans and conduct measurement system evaluations to ensure data reliability and inspection readiness.
• Review and assess supplier quality documentation; participate in supplier evaluations and support resolution of incoming material issues.
• Lead or contribute significantly to structured problem-solving and continuous improvement initiatives within the quality or operations function.
• Provide quality guidance for assigned product lines or processes, including support during engineering changes, deviation management, or issue resolution.
• Review and assess quality impact of process or equipment changes and contribute to technical justifications and change control documentation.
• Communicate quality risks, investigation results, and quality metrics effectively to team leaders, cross-functional stakeholders, and management.

Education / Experience Requirements

Specialized Skills / Other Requirements

TRAVEL REQUIRED : 10 %

The pay range for this position at commencement of employment is expected to be between $82,600- $123,900; however, 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.

If hired, 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.

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At 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.

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 : 877-880-8588 or Talent@Teleflex.com.

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.

© 2025 Teleflex Incorporated. All rights reserved.