Quality Engineer 1
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, Rusch, 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.
OEM - Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary
Quality Support for Manufacturing Value Stream. To bring sound Quality decision making to the team, ensuring effective implementation of the required QMS documentation, and professional communication with all Stakeholders. Quality input on problems of a diverse scope including complaint & NC investigations, demonstrating good judgment in selecting methods and techniques for obtaining solutions, driving corrective actions & verifying effectiveness for assigned area. Oversee inspection & testing requirements, release and supports customer & online issues. Supports and trains other quality team members. Responsible for quality input, review and release during phases of product realization including NPI, Commercialization, Sustaining and End of Life.
Principal Responsibilities
Key responsibilities will include (but are not limited) to the following
Quality support within the assigned project teams to ensure Customer and QMS requirements are implemented and fulfilled to required GMP standards.
Ability to understand, provide input and support specification reviews, factoring in Teleflex capabilities, and drive alignment with customer on acceptance criteria ensuring Teleflex and Customer specifications/ drawings are aligned. Drive for reduction or elimination of variation from processes and inspections.
Trouble shooting quality issues identified using structured problem-solving techniques and driving solutions to reduce non-conformances. NC ownership from all steps - initiation to closure.
Oversee product testing and release activities, including disposition of non-conforming material, the identification of scope, control of related NC material, root cause and appropriate corrective & preventative actions and thorough documentation of same within schedule.
Key driver in responding to and acting on Customer quality feedback and requests.
Ensure that specifications agreed with customers can be fulfilled, incorporate design for manufacturing principles and that Teleflex and Customer specifications and drawings are aligned (NPI & Contract Review).
Quality input and guidance on Validation planning and documentation utilising risk-based (pFMEA) decision making and driving risk mitigation activities into process development and product quality assurance.
Quality input on process changes and related assessment and implementation of change notification.
QA Rep on project team for the identification and implementation of appropriate statistical techniques and visual control systems to monitor the manufacturing processes.
Generating, executing and/or reviewing of inspection plans & records, test methods, risk documents, validation protocols & reports, deviations, work instructions and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Ensure that appropriate quality plans, test methods, test plans, deviations, work instructions, specification and drawings are in place and being adhered to during product development, manufacturing transfer and commercialisation.
Establish and monitor process quality performance to determine when improvement actions are appropriate.
QE review and sign off on QMS documentation and records
Participate or lead cross-functional project teams to eliminate waste and improve performance.
Input to Implementing programmes ensuring compliance with regulatory requirements and documented controls and procedures within area of responsibility.
Provide support for Internal, Customer and regulatory audits.
Ensure & Drive full compliance with regulatory requirements.
Ensure Quality and EHS policies and procedures are adhered to at all times.
Projects as assigned
Quality support on vendor and part appraisal and approval processes.
Education / Experience Requirements
Experienced professional with a good working
knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820 &
the principles of GMP
Degree in an engineering/quality or related discipline
Certified QE desirable
Technical report writing
Process validations/FMEA's and protocols
Good understanding of Statistical analysis
Structured Problem-Solving techniques - Lean Six sigma Green Belt desirable
Understanding of Lean Principles
Ability to drive projects to completion
Guided by the disciplines of due diligence and compliance in all aspects of work.
Specialized Skills / Other Requirements
People
Clear verbal and written communication
Ability to lead meetings
Ability to work in a cross functional team
Self-driven and requires minimal supervision
Strategy
Ability to understand the key drivers of our manufacturing business
Understand the impact of their job on the key business drivers
Basic understanding of other department's impact on the key drivers and how all departments fit together.
Customers and Vendors
Ability to understand customer/vendor relationships
Ability to generate appropriate relationships with customers and vendors
Ability to deal with difficult customer or vendor communications
Ability to influence customers/vendors where necessary
#LI-PD1
Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. If you require accommodation to apply for a position, please contact us at [email protected].
Diversity fosters innovative thinking and entrepreneurship and that's what we are about at Teleflex. We trust and value our people and their diversity and we make it fun to work here. We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in.Our approach is simple, we embrace everyone and want them to feel they belong here.We are building a culture where all employees can bring their best and unique selves to work.If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress.
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, LMA, Pilling, QuikClot, Rusch, 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.
