Quality Specialist
Arlington Heights, IL

Job Description

Date: Jul 4, 2019

Location: Arlington Heights, IL, US

Company: Teleflex

Expected Travel: None

Requisition ID: 914

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 Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. 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 Quality 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

Complete and report on site compliance to procedures

Complaint Handling for site Training Lead

* Maintain training files for site
* Communicate status of training to site Management
* Conduct annual GMP training for the site and as needed for new hires

Project Management of site quality initiatives

MARGINAL RESPONSIBILITIES:

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

Education

* Minimum of a four-year degree in a science or engineering

Work experience

* Minimum of 7 years of experience in Quality Systems preferably in the medical device field.
* ISO/FDA audit experience preferre
* Green belt preffered
* Compliance Wire or other training system experience preferred
* SAP experience preferred
* Compliant handling experience preferred
* Auditor experience/CQA preferred

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.