Quality Engineer -Staff Risk Management Specialist

Date: Jul 14, 2021

Location: Remote, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3927


About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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

This position will support the Design Assurance Knowledge Hub by providing guidance, coaching, training and mentorship to both sustaining and new project teams across all business units on the topics of risk management, root cause analysis and post market surveillance.  In addition to this support, this individual with assist project teams in the completion of risk management files.

Principal Responsibilities

•    Serve as the subject matter expert in risk management procedures including updates to work instructions, standard operating procedures and other risk management tools.
•    Define success metrics for the global roll out of new risk management process, procedures and tools.
•    Provide virtual instructor-led training on risk management and root cause analysis to project teams around the world.
•    Assist in the identification of use error root cause, recommend mitigation and participate in design validation planning efforts to provide evidence of effective risk controls.
•    Provide guidance and coaching to project teams on risk management deliverables for each phase of the product development process.
•    Assist in analyzing product complaints, medical device reporting (MDR), and other post-market surveillance data in a timely fashion and assist project teams in updating risk management files.
•    Support product teams in identifying and implementing risk mitigations, assist with updates to risk analyses/Failure Mode Effects Analysis, and ensure product line compliance to product risk management procedures.
•    Ensure that well-structured, periodic complaint/MDR review sessions are conducted with appropriate input from cross-functional teams and that the reviews are documented and communicated to leadership in cooperation with the Product Specialist, Product Surveillance, Product Engineers, Manufacturing, and Quality Assurance
•    Work with product teams, this individual will be a central source of information for risk management guidance and utilize technology and tools to continually learn, innovate and share this knowledge with other associates.

Education / Experience Requirements

•    Bachelor's degree in Engineering, Science or technical field with 10+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality in the medical device industry.  
•    At least 7 years’ experience with product quality and risk management processes (risk management plans and reports, FMEA’s, Benefit Risk Analysis, Hazards Analysis) 
•    Experience with EU MDR remediation/implementation 
•    Experience with pre-submissions, PMA & 510k submissions to the FDA, root cause analysis and general product quality experience in healthcare and FDA requirements in risk management and root cause analysis 

Specialized Skills / Other Requirements

•    Excellent interpersonal, organizational as well as verbal and written communication skills
•    Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803 and 820, ISO13485, ISO14971, IEC-62366, FDA Guidance documents and European Medical Device Regulations in addition to IEC, ISO and UL standards related to medical devices.  
•    Strong computer literacy with proficiency with MS Excel and PowerPoint
•    Strong analytical and organizational skills, flexibility, and attention to detail
•    Experience applying Lean and Six Sigma tools in continuous improvement projects. Lean Six Sigma: Black Belt required 
•    Process-driven, passion to details and ability to drive complex program through timetable and overcome obstacles.
•    Successful experience working independently and on cross-functional teams
•    Excellent collaboration, communication, leadership, influencing, and presentation skills. Ability to interface with internal and external customers in a highly professional manner

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: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.

© 2021 Teleflex Incorporated. All rights reserved.