Expected Travel:

Up to 50%\n

Requisition ID:

14037 About Teleflex Incorporated\nAs 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\nTeleflex 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\n

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 assignedEducation / Experience Requirements\n
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 requiredSpecialized Skills / Other Requirements\n
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\n

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\n

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.\n

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 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.\n

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. It's 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.\nPatient 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 we'll 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-DR1At 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. 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