Quality Auditor

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. Its critical to stay curious, embrace feedback, and look for opportunities to streamline processes or solve problems more effectively. Individual contributors should take initiative to learn from experiences, adapt to change, and apply new knowledge to drive better outcomes. By consistently striving to improve, they add value to their team and support the organization's growth and success.
• Culture and Values - Living our culture and values is essential to fostering a positive, collaborative work environment. Individual contributors demonstrate this by treating others with respect, acting with integrity, and contributing to an inclusive and supportive team culture. Its critical to hold oneself accountable, align actions with shared values, and support the broader mission of the organization. By consistently modeling these behaviors, individual contributors help strengthen the workplace culture and positively influence those around them.

TELEFLEX QUALITY BEHAVIORS:

As a member of the QARA team, you play a critical in our mission to improve the health and quality of people's lives. Below are the quality behaviours that we expect all QARA employees to exhibit every day.

Patient Focused

• We prioritize our patients and users in our decision making.
• We understand our products and recognize our actions affect product quality.
• We understand the impact of product quality on user and patient safety.

Accountable

• We show up prepared and if we say well do it, we do.
• We learn from mistakes and address them quickly.
• We speak up and take responsibility.

Preventive

• We proactively look for and address things that could go wrong.
• We speak up when we notice poor quality.
• We correct poor quality and prevent recurrence.

Solution Minded

• We bring solutions to identify problems and are open to change.
• We share and implement ideas to continuously improve.
• We evaluate fully and investigate to root cause.

#LI-DR1

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 Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

2026 Teleflex Incorporated. All rights reserved.