Quality Engineer II, Design Assurance

Date: Oct 8, 2024

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel : Up to 25%

Requisition ID :11091

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™, QuikClot™, LMA™, Pilling™, 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

As a member of a cross-functional team, the Quality Engineer II, Design Assurance is responsible for identifying and implementing quality improvement measures to ensure state of the art manufacturing of Intra Aortic Balloon Catheters. Reporting to an experienced engineer, the position identifies and implements production and process control improvements in extrusion, bonding, balloon wrapping, and manual assembly. As the voice of Quality, the Quality Engineer will champion best practices in quality, teamwork, and statistical methods, promoting their use across the organization.

Principal Responsibilities

• Partner with R&D, Regulatory Affairs, and Operations to support activities in product and process design such as process development, process validation, test method development and validation, fixture design and qualification, and ensure appropriate execution of necessary updates to design history files.

• Maintain and update 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.

• Partner with operations quality engineers to ensure design controls and PFMEA to DFMEA & EDO linkages are maintained. Ensure proper implementation of process controls by reviewing production lines.

• Develop and validate 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.

• Use quality tools and statistical techniques to determine sample sizes, collect and summarize data, determine data distributions, identify relationships between variables, design and analyze experiments, calculate reliability, determine process and performance capability, draw conclusions with confidence, and make statistically supported decisions.

• Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.

• Understand 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.

• Perform root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.

• Provide input on projects for supplier process improvement and process qualifications.

Education / Experience Requirements

• B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered).

• 2 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry).

Specialized Skills / Other Requirements

• ASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB).

• Basic understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.

• Proficient in MS Office, and Minitab or other statistical softwares.

• Strong organizational and time management skills to meet deadlines while managing multiple projects.

• Strong analytical and critical thinking skills.

• Proficient in technical report writing and review.

• Strong verbal and written communication skills.

• Foster a positive culture of growth, collaboration, and achievement across the organization.

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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, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, 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™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2024 Teleflex Incorporated. All rights reserved.