Quality Assurance Manager

Date: Aug 4, 2022

Location: Wallingford, CT, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6471

 

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

The Quality Assurance Manager will own responsible for improving and managing the QMS system and all quality areas for the site, the legal manufacturer of medical devices.  Provides direction and interpretation of policies to all departments for compliance with the company quality system and government regulations. Facilitate corrective action and continuous improvement to enhance the effectiveness of the quality system.

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Principal Responsibilities

  • Administer the quality system to assure that all lots of finished products manufactured in Wallingford, CT meet all internal specifications, customer expectations, and regulatory requirements.
  • Facility management representative for Quality System administration.
  • Administer and review the facility Corrective and Preventive Action System; identify quality problems and initiate corrective action.
  • Administer the control of and provide for the disposition of non-conforming products.
  • Administer document and data control system, control of quality records and documents. 
  • Manage and execute the Internal Audit Process
  • Develop, review and approve inspection criteria and procedures to assure product quality.
  • Administer the inspection of incoming materials and components; in-process components, assemblies, and packaging; and finished products.
  • Administer the QA Department for the most efficient utilization of available resources.
  • Assist with customer complaints investigations and documentation as needed. 
  • Provide all necessary support to strategic projects impacting the Wallingford facility.
  • Review and approve validation protocols and reports.
  • Establish and control the budget for the Quality Assurance Department.
  • Assume the role of “contact person” for all Food and Drug Administration investigations and other regulatory audits.
  • Responsible for enforcing all local, state, federal, and safety regulations/policies/procedures.
  • Complies with all policies/procedures/practices through consistent application of sound Quality Assurance principles.
  • Ensures compliance with quality policies/procedures/practices through appropriate communication, training, and education of sound Quality Assurance principles.
  • Provide other departmental support as requested by the immediate supervisor.
  • Adhere to and ensure compliance with Teleflex’s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.
     

Education / Experience Requirements

  • Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields. Advanced degree (MS in the technical area), MSc preferred
  • ASQ Certified Quality Engineer (preferred).
  • 7-10 years of related experience.
  • 5-7 years of progressive quality assurance experience in a manufacturing environment within the Medical Device Industry.
  • 1-2 years of auditing experience
     

Specialized Skills / Other Requirements

  • Minimum 5 years experience with US and international medical device regulations, standards, and guidance documents. Including:
    • 21 CFR 820 US FDA Quality System Regulations.
    • ISO 13485 Medical devices – Quality management system – requirements for regulatory purposes.
  • Project Management skills and experience.

TRAVEL REQUIRED: 0-10 %
 

WAGE RANGE/RATE: $100,600-159,000 based on experience and qualifications


 

 

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: New Haven
Nearest Secondary Market: Hartford