Staff Quality Engineer Lead

Date: Sep 30, 2022

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 7006

 

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

The Principal Quality Engineer is responsible for leading the Quality Engineering team to improve 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, and to work and communicate across various levels of the organization. This position, under the direction of the Quality Assurance Manager, works closely with R&D, Design Assurance, Sustaining Engineering, and Manufacturing. This role will be integral in the development of new products and supporting day-to-day operations.

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 Engineers and Quality Technicians
•    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 the functional area
•    Define, plan and execute major projects related to product quality and regulatory compliance
•    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
•    Eight (8) 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, EU MDR)
•    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 staff and Project Management teams to define deliverables
•    Strong problem-solving skills
•    Ability to lead and provide direction through solid oral and written communication skills
•    Self-starter with the ability to quickly learn about new processes with very little information provided
•    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)


TRAVEL REQUIRED: 5 %

 

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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.

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