Compliance Specialist

Date: Feb 19, 2021

Location: Arlington Heights, IL, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3467 

 

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

This Compliance Specialist position will support core quality management system processes to ensure compliance with applicable medical device regulations through a variety of roles and responsibilities supporting the Quality Assurance (QA) team across multiple functionalities.

Principal Responsibilities

Owner of Internal Audit Program (Lead Auditor)
•    Scheduling the Internal Audits
•    Conducting Internal Audits
•    Managing/Leading the Audit team
•    Reporting on Audit results
•    Maintaining Audit Files
Lead Supplier Auditor for Site
•    Scheduling the Supplier Audits
•    Conducting Internal Audits
•    Reporting on Audit results
•    Maintaining Audit Files
•    Add suppliers to Approved Supplier List as needed
Complaint Handling Lead for site
•    Receive and investigate customer complaints
•    Ensure corrective actions are completed on time
Complete and report on site compliance to procedures
Project Management of site quality initiatives
Support of site external audits
Support of the CAPA program
Support of nonconformance management as required by personnel needs
Support of batch record review and release as required by personnel needs
Review and revise procedures as required
 

Education / Experience Requirements

Bachelor’s degree in a science or engineering or equivalent experience in an FDA regulated environment
Minimum of 5 years of experience in Quality Systems preferably in the medical device field.
ISO/FDA audit experience preferred
Green belt certification preferred 
Compliance Wire or other LMS administration experience preferred 
SAP experience preferred
Complaint handling experience preferred
Auditor experience/CQA 
 

Specialized Skills / Other Requirements

Mastery of computer software programs such as Microsoft Word, Excel, and PowerPoint 
Fluid working knowledge of Quality Management Systems and Procedures
Report writing, presentation, and metrics tracking

Ability to:
Communicate clearly and concisely, both orally and in writing.
Collect and summarize data; highly organized, self-motivated and detail oriented.
Read and interpret a variety of documents and work instructions with minimal direction.
Prepare and maintain concise and complete records and reports.
Establish and maintain effective working relationships with fellow employees.
 

 

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: Chicago