Quality Assurance Manager

Date: Jul 16, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4335

 

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

As part of the Teleflex Global Operations Division, and as a member of the Maple Grove Leadership Team, the Quality Assurance Manager is responsible for managing the site’s overall quality system in alignment with the company’s global policies.  The Quality Assurance Manager drives the execution of deiverables by proactively managing a high-performance team while monitoring and reporting the site’s quality metrics, identifying and addressing quality issues and effectively organizing and leading external audits. This position will work cross functionally with a variety of departments including the Post Market Surveillance Team to manage and address customer complaints.  

Principal Responsibilities

•    Lead the Quality Assurance team, which includes Quality Engineering, Quality Systems, Quality Control, and Calibration. 
•    Proactively manages performance and team dynamics to ensure that a fair, professional, and high-performance environment, in alignment with the company’s core values. 
•    Develops individual and organizational capabilities to build bench strength while delivering results.
•    Establish, implement, and maintain an effective, efficient, and cohesive site-specific quality system that ensures compliance with FDA and ISO expectations, in alignment with the company’s global policies. 
•    Responsibility to serve as Management Representative.
•    Organize, lead, and facilitate FDA and Notified Body audits, inspections, and correspondence.
•    Create internal audit schedule and ensure timely execution.
•    Drive pragmatic, responsive, and timely execution of Non-Conformances and CAPAs.
•    Manage and report on site quality metrics – monitoring, planning, and executing to improve performance.
•    Identify and respond to trends and quickly address underperforming metrics.
•    Partner with Design Teams to ensure the successful transfer of new designs from development to production.
•    Partner with Operations to maintain supply continuity, execute validations and drive continuous improvement.
•    Support Supplier Quality in the execution of supplier audits, additions, changes, and requests.
•    Support Post Market in complaint investigations, risk assessments, and field actions.
•    Identify, execute, and collaborate cross functionally on manufacturing scrap and cost reduction projects.
•    Identify, drive, and support optimization and harmonization opportunities to increase effectiveness and efficiency.
•    Provide input into regional and corporate strategic initiatives and execute at a site level.
•    Execute and make decisions with limited supervision; quickly and clearly escalate issues as appropriate.

Education / Experience Requirements

•    B.S. Degree in Engineering or Physical Sciences required. Master’s Degree or MBA preferred.
•    Minimum of 5 years related quality experience in a manufacturing environment.
•    Minimum of 2 years’ experience supervisory or management experience.
•    ASQ CQA or CQE certification preferred.
•    Broad engineering experience in manufacturing operations including new product development, cost reduction, and quality engineering.
•    Knowledge of clean room controls, medical device development and device assembly. 
 

Specialized Skills / Other Requirements

•    Can establish work direction and manage a team of engineers and technicians.
•    Capable of defining, organizing, managing, and executing individual and team tasks.
•    Ability to collaborate with various levels within and outside the company, as well as across functions.
•    Experience operating in a fast-paced, dynamic manufacturing environment. 
•    Effective verbal and written communication – to team, peers, and management.
•    Statistical and engineering knowledge (DOE, SPC, sampling, validation, tolerance analysis)
•    Pragmatic and methodical root cause analysis and problem-solving approach.
•    Strong understanding of medical device industry regulations and quality system design/management. 
•    Experience with FDA Quality Systems Regulations, ISO 13485, Quality Certificates, GMP, and MDSAP
 

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