Quality Supervisor

Date: Jun 22, 2022

Location: Wallingford, CT, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6612 

 

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 Functions The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. 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 Supervisor leads the Quality Control team and directly supervises day-to-day activities supporting Wallingford, CT Manufacturing Operations. Ensures all testing & quality requirements related to all products meet company and regulatory requirements. Responsible to provide technical leadership, daily supervision, training development, and certification of inspectors, while coordinating and prioritizing production routine testing, product release, and processing non-conformances.

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Principal Responsibilities

  • Supervises and prioritizes Quality Inspector activity in support of routine testing, product release, incoming inspection, process non-conformances, etc.
  • Assist in ensuring all lots of finished products manufactured in Wallingford, CT meet all internal specifications, customer expectations, and regulatory requirements.
  • Provides training development where needed.
  • Assist as a technical expert in relevant technical issues, protocols, SOPs, methods, etc. 
  • Implements cost improvement projects within the department and in support of internal customers.
  • Track, report, & improve key quality indicators for quality compliance, productivity, and efficiency.
  • Provides input to annual spending and headcount budgets.
  • Acts as the contact for functional groups, nonconforming products, and production issues
  • Performs Non-Conformance (NC) investigations and Corrective Action / Preventative Actions (CAPA).
  • Participates in FDA inspections, ISO certifications, surveillance audits, etc.  
  • Perform performance review for direct reports within assigned time frames.
  • Coordination and/or complete calibration of test equipment and gages. Maintain calibration records and work with calibration vendors. Assist with determining gauge requirements.
  • Administer customer complaint investigations and documentation as needed. 
  • Assist in 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 
  • 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

  • Associate, equivalent, or higher degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields. 
  • 5-7 years of quality assurance experience in a manufacturing environment. Within the Medical Device Industry preferred.
  • Minimum three years of supervisory experience.
     

Specialized Skills / Other Requirements

  • Minimum three 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.
  • Must have strong written and verbal communication skills. 
  • Must be able to effectively present at staff and department meetings.
  • Knowledge of MS Office Suite.


TRAVEL REQUIRED: 0-10 %
 

 

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