Quality Engineer II

Date: Jan 7, 2022

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 5383

 

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.

 

US COVID-19 Vaccination Requirements

Teleflex is focused on the health and safety of our employees, their families, and our customers. Teleflex will comply with US government regulations regarding COVID-19 vaccination requirements for US workers. To ensure we are prepared for all applicable vaccination requirements, Teleflex is currently collecting vaccination status and accommodation requests from our US based employees.

Employees and new hires in sales or field-based roles that require vendor credentials to access medical facilities as an essential function of the job, may be required to obtain the COVID-19 vaccination based on customers/site requirement. This requirement is independent of Teleflex policy or any applicable US governmental regulations.

 

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 II 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 in order to work and communicate across various levels of the organization. This position, under the direction of the Senior  Quality Engineering Manager, works closely with R&D, Supply Chain Management, and Manufacturing to support day-to-day operations. The role is 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.
•    Support investigation of customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s and report generation.
•    Coordinate the Change Impact Assessment activities 
•    Support site initiatives such as Cost of Quality, Defects Per Million, and Continuous Improvement Projects.
•    Mentor, train and provide work direction to quality engineering technicians
•    Participate in pre-design freeze quality activities
•    Reduces manufacturing process defects through corrections implemented.
•    Revises simple updates to manufacturing or quality SOPs and other related documentation.
•    Ensure company policies and procedures are followed.
•    Establish and maintain effective working relationships with fellow employees.
 

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences required.
•    2 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.)
•    Mastery of computer software programs such as Microsoft Word, Excel, and PowerPoint 
•    General understanding of the quality system and regulatory compliance.
 

 

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: Minneapolis