Quality Systems Lead

Date: Jul 18, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4336

 

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 Quality Systems Lead (QSL) establishes, implements, and maintains quality processes and systems to enable site’s continued compliance and goal attainment. The QSL provides metrics follow up, quality assurance activities timeliness, and ensures cost of quality task completion. Additionally, the QSL assists in special projects aimed to reduce waste and optimize resources in quality systems and processes. The QSL interacts with various areas in the organization at the local, regional, and global level to meet organizational goals and leads applicable activities. 

Principal Responsibilities

•    Implementation and maintenance of an effective, quality system(s) that ensures compliance to applicable medical device regulations
•    Establish processes for site metrics management and reporting
•    Local scorecard and quality data maintenance
•    Oversight of site management review and reporting on performance of the QS to management
•    Oversight of site internal and external audit programs; support in the organization and management of FDA and Notified Body audits and inspections and ensure timely response to findings
•    Assure implementation of corporate policies, procedures, and work instructions, as applicable
•    Lead and/or support quality corrective and preventive action (CAPA) projects 
•    Lead and/or support quality special projects related to cost of quality (CoQ)
•    Responsible for change management (PLM) and master data management (ERP) and ensuring conformance to applicable requirements
•    Responsible for QS training and ensuring conformance to applicable requirements
•    Staff, develop, organize, and direct a team capable of maintaining and improving the site’s Quality System and building organizational capability for its maintenance.
•    Partner with Regulatory to develop and execute compliance related strategies
•    Identify, drive, and support optimization and harmonization opportunities to increase effectivity and efficiency

MARGINAL RESPONSIBILITIES: 
•    Lead and/or support various Quality Management System activities, as applicable
 

Education / Experience Requirements

•    BA/BS in engineering or related field required
•    Ten years of relevant experience in a medical device industry
•    Minimum 5 - 7 years of experience managing a team
•    Advanced knowledge and experience with ensuring QMS compliance to all applicable regulations and standards
•    In-depth knowledge of medical device good manufacturing requirements (FDA)
•    Certified Lead Auditor ISO 13485
•    ASQ certification desired (CQE or CQA)
 

Specialized Skills / Other Requirements

•    Ability to set direction and manage a multi-site team of managers and individual contributors
•    Ability to structure and direct teams in alignment with cross functional teams
•    Ability to collaborate with personnel at all levels both within and outside the company
•    Effective verbal and written communication – to teams, peers, and senior management
•    Structured and methodical problem-solving approach
•    Thorough understanding of medical device industry regulations and quality system design/management
•    Ability to foster a positive culture of growth, collaboration, and achievement across the organization
 

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