Sr. Quality Engineer, MDR

Date: Feb 18, 2021

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3369

 

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.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. 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 Senior Quality Engineer is responsible for improving quality, production, and processing methods and controls in manufacturing to achieve operational excellence. This position requires the ability to build and maintain strong relationships with manufacturing engineering, material planning, and production, to work and communicate across various levels of the organization. This position, under the direction of the Senior Product Quality Manager, works closely with R&D, Supply Chain Management, and Manufacturing to support the day-to-day operations. This role will be integral in the process validation of new products as they move through development and into production. 

Principal Responsibilities

•    Determine test requirements, test methods, sample sizes and statistical analysis for qualification/verification studies for manufacturing.
•    Develop verification, validation and qualification plans and reports for manufacturing.
•    Initiate and lead non-conformance investigations regarding component failures, finished goods failures, and product returns.  This includes but is not limited to performing risk analysis, determining root cause and recommending corrective action.
•    Investigate customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s and report generation.
•    Lead root cause analysis and CAPA closure 
•    Leads efforts to qualify specification changes and qualify new test methods 
•    Coordinate the Change Impact Assessment activities 
•    Mentor, train and provide work direction to quality engineering technicians and new quality engineers
•    Participate in pre-design freeze quality activities
•    Proactively eliminates possible manufacturing process defects.
•    Authors new SOPs and other documentation.
•    Demonstrates a high level of proficiency in functional area
•    Define, plan and execute major projects related to product quality
•    Ensure company policies and procedures are followed, taking timely corrective action with the help of HR when necessary
 

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences required
•    Five years of related experience required
 

Specialized Skills / Other Requirements

•    Demonstrates an in-depth understanding of functional area (process statistics, risk management, metrology and calibration, ISO13485, FDA QSRs.)
•    In-depth understanding of the quality system and regulatory compliance
•    Critical thinker and active listener with good time management skills in order to work with Project Management teams to define deliverables
•    Strong problem-solving skills
•    Solid oral and written communication skills, including the ability to write technical reports and presentations
•    Self-starter with the ability to quickly learn about new processes with very little information provided
•    Oral and written communication skills, including the ability to write technical reports and presentations
•    Prior Product Quality experience in manufacturing and analytic approach to problem-solving
•    Knowledge of quality-related tools including, but not limited to, SPC, DOE and Quality Systems
•    Lean Six Sigma training (Certification preferred)
 

 

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.


Nearest Major Market: Boston