Quality Analyst

Date: Aug 4, 2022

Location: Wallingford, CT, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6472 

 

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 Analyst will support Document / Record Control, Training Systems, Quality Control, and Quality System operations.   

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Principal Responsibilities

  • Supports Document Control and Change Management processes which include, but are not limited to the following:
    • Maintain quality system documentation and files.
    • Manage the process of assignment and monitoring of document numbers.
    • Update and revise operating procedures as approved through Change Management.
    • Manage the local documentation process.
    • Manage distribution process of controlled documents.
    • Assist in the remediation of documentation files.
    • Provide support in editing and updating documents and electronic filing databases. 
    • Participate in and manage data entry and maintenance of records.
    • Support the development of all types of documents and reports.
    • Provide training and mentoring to personnel on the change management process.
  • Maintain the Training system via the following tasks:
    • Maintain the training database.
    • Generate Key Performance Indicators, and KPI reports on associated on-time training, and provide reports related to outstanding and delinquent training to management and supervisory personnel.
    • Provide training and mentoring to training personnel on the training process.
  • Participate and support the Internal Audit program.
  • Participates in FDA inspections, ISO certifications, surveillance audits, etc.  
  • Assist as a technical expert in relevant technical issues, and process improvements and projects.
  • Assist in support of routine testing, product release, incoming inspection, non-conformances, etc.
  • Assist in customer complaint investigations and documentation as needed. 
  • 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

  • Associate, equivalent, or higher degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields. 
  • Minimum three years of experience in documentation control, technical writing, and exposure to the training environment
  • Strong attention to detail and ability to meet deadlines.
  • Knowledge of Quality Management Systems under ISO 13485:2016
  • Experience in the medical device industry as an internal auditor.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions. 
     

Specialized Skills / Other Requirements

  • Minimum two years of 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.
  • Good negotiation, problem-solving, verbal and written communication, and project management skills.
  • Proficient with Microsoft Office Suite

 

TRAVEL REQUIRED: 0-10 %

 

WAGE RANGE/RATE: $57,000-85,700 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