Senior Quality Engineer, Quality Systems

Date: Jan 15, 2025

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel : Up to 10%

Requisition ID :11625

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.

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

Improve and maintain the quality system in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System (QMS). This position requires exceptional knowledge of national and international quality system requirements, excellent organizational skills, and the ability to perform at high levels in a fast-paced, dynamic environment.

Principal Responsibilities

• Quality System compliance to ISO 13485, MDD, EU-MDR, MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and other regulatory requirements applicable to the QMS.

• Support the maintenance and continuous improvement of the ISO 13485 quality management system processes.

• Support the implementation of Teleflex global quality system processes, including but not limited to Change Management, Training, NC, CAPA, Quality Data Analysis Review (QDAR), Auditing, and Management Review.

• Manage and support the learning management system, ComplianceWire. Promote effective and timely completion of training.

• Coordinate and support the Internal Audit program. Promote effective and timely completion of audits to ensure compliance to audit schedules.

• Generate, interpret, analyze, and communicate results using management tools, graphs, and reports.

• Conduct Internal Audits per relevant audit schedules.

• Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.)

• Coordinate, support and participate in external audits (including audit facing Quality System Lead when required) with Notified Bodies/ and other government agencies.

• Review and recommend improvements to the implemented Quality Management System (procedures and work instructions)

• Prepare and deliver training and orientations on global quality system requirements and company processes to employees.

• Conduct technical reviews to ensure that the Quality System remains in compliance with all applicable laws and standards, and that the system is as efficient and effective, as possible.

• Provide Quality Systems support to all areas of the QMS, including, PMS, RA, R&D, Supplier Quality, Customer Services and Marketing Communications ensuring compliance is always maintained.

• Project Manage Quality System related project activity as required.

• Drive regional and local quality initiatives.

Education / Experience Requirements

• Bachelor of Science in Engineering, Technical or Life Science discipline; or equivalent experience.

• At least 5 years of experience in Quality Systems or Quality Engineering or other applicable experience with a minimum of 3 years in the medical device industry.

• Exceptional knowledge of national and international quality system requirements (e.g. QSR, ISO 13485, MDSAP) and related ISO/EN standards.

• Strong written, oral, interpersonal, analytical, problem-solving skills; and statistical application experience.

• Excellent level of organizational skills and the ability to multitask while ensuring a high level of attention to detail.

• Strategic yet hands-on when needed with a high degree of energy and drive, and the ability to seek function and process improvements continually.

• Open and direct communication style and a vision for continuous improvement and excellence.

• Experience with Class II and/or III sterile devices (preferred).

Specialized Skills / Other Requirements

• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Teleflex complies.

• Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in complicated, advanced engineering or mathematical formats.

• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to analyze a variety of technical instructions in mathematical or diagram form and interpret various abstract and concrete variables. Ability to read technical and clinical literature and documents and extract important concepts.

• The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.

• Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.

• Teleflex is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

TRAVEL REQUIRED: 10% Overnight domestic and/or international travel may be required.

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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, 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: 877-880-8588 or Talent@Teleflex.com.

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.

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