Quality Auditor
**Date:** Aug 4, 2026
**Location:** Morrisville, NC, US
**Company:** Teleflex
**Expected Travel** : Up to 50%
**Requisition ID** :14037
**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, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. 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**
Teleflex is seeking a Quality Auditor to join our Strategic Compliance department. The successful candidate must possess the ability to analyze and assess quality management systems to ensure compliance and conformance to the intent of the applicable regulations and standards. The ability to interpret regulations and standards, be aware of industry best practice and focus on ensuring safe and effective product outcomes is necessary for this position.
This position is based at our Morrisville, NC office.
**Principal Responsibilities**
- Plan, execute and document internal quality system audits
- Track audit observations and follow up on resolution
- Compile and report audit metrics
- Train and mentor site quality auditors in general quality system auditing practices
- Provide interpretation and consultation to project teams on regulations and standards
- Assist with the development, implementation and maintenance of the corporate auditor training program
- Assist in training of new auditors
- May present educational content and guidance to other functions
- Adhere to and ensure compliance with the Teleflex Code of Ethics, all company policies, rules, and procedures
- Complete other duties and tasks, as assigned
**Education / Experience Requirements**
- Bachelor's degree in technical field required
- Minimum of 5 years of experience in a quality or regulatory role in the pharmeceutical or medical device industries
- Minimum of 2 years of experience performing internal or supplier audits as the lead auditor
- Fluency in English required
**Specialized Skills / Other Requirements**
- Understanding and application of quality systems
- Fluency in Spanish, German and/or Czech desired
- In depth understanding and interpretation experience for the following regulations and standards:
**Required:**
FDA Title 21 CFR 820 QMSR
ISO 13485:2016
**Desired:**
MHLW No. 169; Ministerial Ordinance
SOR 98-282; Medical Device Regulations
TG(MD)R: Therapeutic Goods (Medical Devices) Regulations 2002
ANVISA RDC 665/2022
EU MDR 2017/45 European Medical Device Regulations
- Strong communication and interpersonal skills with a broad spectrum of people from varying backgrounds, education and experience.
- Ability to understand technical operations, processes and validation.
- Critical thinking, logic and analytical skills
- Documentation, organization and time management skills
- Technical writing skills
- Ability to operate with limited supervision within defined parameters
INDIVIDUAL CONTRIBUTORS:
- Commitment to Goals - A strong commitment to achieving goals is essential for personal and team success. It requires taking ownership of tasks, staying focused on priorities, and consistently delivering high-quality work. Being proactive, managing time effectively, and seeking support when needed are critical to meeting deadlines and overcoming challenges. By aligning personal efforts with team and organizational objectives, individual contributors play a vital role in driving results and advancing shared goals.
- Continuous Improvement - Continuous improvement means actively seeking ways to enhance your work, skills, and contributions. It's critical to stay curious, embrace feedback, and look for opportunities to streamline processes or solve problems more effectively. Individual contributors should take initiative t