Quality Manager

Date: Apr 6, 2021

Location: Plymouth, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3721

 

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.

 

OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Supervise and manage the development and maintenance of all plant quality systems including supplier development, calibration, internal auditing, CAPA, quality engineering, production support efforts including validation/testing in the Plymouth, MN OEM facility. Manage OEM complaint handling. Establish and implement compliance training programs. Ensure that necessary regulatory corporate compliance systems are in place and adhered to. Represent quality for new product development and provide statistical support as needed throughout the plant. This position serves as the Management Representative for the Plymouth MN OEM facility. 

Principal Responsibilities

•    Management and development of staff in the facility; ensure that CAPA, supplier/internal audits, calibration system, supplier development engineering, quality engineering, and complaint handling are staffed with qualified employees; ensure that direct reports are appropriately trained and have resources to do their assigned tasks; provide reports with career development opportunity
•    Develop quality systems and establish procedures in compliance to FDA regulations and ISO requirements
•    Work on assigned projects with limited supervision
•    Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives. Support protocol, procedure and specification development.
•    Complete special assignments as assigned by the Director of QARA
•    Generally operate with appreciable latitude for actions or decisions on day-to-day activities; receive guidance on novel or controversial problems
•    Outline and implement improvements to Quality System, and processes. 
 

Education / Experience Requirements

•    B.S. Degree in Engineering, Physical Science or similar. Masters Degree or MBA preferred.
•    Minimum of 3 years medical device industry experience
•    Minimum of 3 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 in extrusion, clean room controls, medical device development and device assembly desirable 
 

Specialized Skills / Other Requirements

•    Strong leadership and management skills
•    Demonstrated experience in mentoring and coaching others
•    Regulatory, cGMP, QSR, knowledge base
•    Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison)
•    Strong computer skills  (i.e. database development, statistical software and analysis, word processing for report generation, etc.)
•    Strong negotiation and problem-solving skills
•    Ability to operate and communicate effectively with multiple teams
•    Supplier auditing knowledge and ability (i.e. ASQ-CQA, internal/external courses, seminars)
•    Able to understand blueprints, tolerance analysis and related knowledge
•    Strong reasoning/analytical skills including the ability to, support and prioritize projects and adapt to shifting priorities 
•    Work with minimal supervision
•    Able to successfully resolve problems and conflicts 
 

 

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