Quality Systems Specialist

**Date**:Apr 21, 2025

**Location**: Benito Juárez, CMX, MX

**Company**:Teleflex

**Expected Travel**: Up to 10%

**Requisition ID**: 12102

**About Teleflex Incorporated**

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose.

**Latin America -** The Latin America Region of Teleflex is headquartered in Morrisville, North Carolina, and supports our customers, distributors, sales managers and specialists in Mexico, Brazil, Colombia, Chile, Argentina and Puerto Rico. The Latin America Region sells a broad spectrum of medical devices and related products in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. As Teleflex grows and expands its portfolio, we will continue to grow our presence in Latin America. 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 Systems Specialist will provide professional Quality System Document Control service by processing and maintaining written documents and drawings in accordance with internal procedures and external regulations/standards (ISO 13485, 21 CFR 820, EU MDR and any other regulatory requirements applicable). Provide guidance and assign training to Teleflex personnel. Participate in Quality System related projects as required. Coordinate and manage records management activities for Teleflex.

**Principal Responsibilities**
- Document Control: Assess, process, and maintain written Quality System documents and drawings in an electronic system.
- Perform Quality Systems Specialist / Change Analyst duties in an electronic documentation management system as needed.
- Review proposed changes, change notes and approvals; edit spelling, grammar and formatting.
- Prepare and process change orders.
- Prepare and process biennial reviews and provide instructions and reminder reports to document owners.
- Maintain databases/indices, distribution, and retrieval systems.
- Assign and track document and other control numbers.
- Assist with document control tracking and metrics.
- Issue periodic status reports (e.g. Overdue Reviews, Issued Documents).
- Training: Assess, process, and maintain Quality System training through an electronic learning management system.
- Process training requests.
- Update and maintain training in an electronic learning management system.
- Provide guidance on training assignments in an electronic learning management system.
- Assist with Quality System training and tracking.
- Participate in Document Control and records retention/storage related activities and projects as required
- Assist with Quality System related document control and training projects as required.

**Education / Experience Requirements**
- English proficiency is a must (B2 level and above)
- 2-year degree preferred; 2-3 years’ experience in the medical device industry including knowledge of FDA and ISO and other related industry regulations highly desired
- Experience in working with electronic document management system Agile desired
- Experience in working with electronic training system ComplianceWire desired
- Experience working in Quality Systems desired

**Specialized Skills / Other Requirements**
- Strong proofreading skills.
- Attention to detail and accuracy is essential; good documentation practices.
- Service oriented.
- Able to communicate diplomatically and effectively (both verbally and in writing).
- Able to prioritize projects and adapt to shifting priorities.
- Able to clearly provide feedback to department management.
- Self-driven with the ability to work independently and/or as a team player.
- At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._
- Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, 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._
- © 2025 Teleflex Incorporated. All rights reserved._

LI-JA1