Quality Engineer 3

Teleflex; Limerick; On-site; EUR 60,000 - 80,000; Full time

Job summary

A global medical technologies provider in Ireland seeks a Quality Lead to oversee product realization phases, ensuring compliance with regulatory and quality standards. The candidate should have experience in statistical analysis and problem-solving techniques, alongside a relevant degree. This role involves direct involvement in quality oversight, documentation, and corrective actions throughout product development and commercialization.

Qualifications

• Seasoned professional with full working knowledge of regulatory requirements.
• Ability to drive projects to completion.
• Technical report writing experience.

Responsibilities

• Oversee all phases of product realization including NPD and NPI.
• Ensure compliance within GMP and QMS requirements.
• Drive solutions to reduce non-conformances during development.

Skills

EN ISO 13485 knowledge

Proficient in Statistical analysis

Structured Problem-Solving techniques

Lean Six Sigma Green Belt

Understanding of Lean Principles

Education

Degree in an engineering/quality or related discipline

Certified QE

Job description

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.

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 Lead for all phases of product realization including NPD, NPI, Commercialization, Sustaining and End of Life. To bring creative, innovative and sound Quality decision making to the team, ensuring effective implementation of the required QMS documentation, and professional communication with all Stakeholders. Quality oversight on problems of 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 QA inspection, testing & release. Guides, supports and trains other quality team members.

• Monitor and drive compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area.
• Trouble shooting quality issues identified during product development and commercialisation and driving solutions to reduce non-conformances.
• 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 lead on vendor and part appraisal and approval processes.
• Quality lead on process change and related assessment and implementation of change notification
• Working with project team in the identification and implementation of appropriate statistical techniques and visual control systems to monitor the manufacturing processes.
• 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.
• Ability to understand and lead 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.
• Ensuring that all design/specification /process changes are in line with customer contractual agreements and product safety while facilitating progressive and efficient change management.
• 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 CAPA actions and thorough documentation of same within schedule.
• Establish and monitor process quality performance to determine when improvement actions are appropriate.
• Key driver in responding to and acting on Customer quality feedback and requests.
• QE review and sign off on QMS documentation and records
• Participate or lead cross-functional project teams to eliminate waste and improve performance.
• Develop and implement programmes to ensure compliance with regulatory requirements and documented controls and procedures within area of responsibility.
• Provide support for Internal, Customer and regulatory audits.
• Ensure full compliance with regulatory requirements.
• Ensure Quality and EHS policies and procedures are adhered to at all times.
• Projects as assigned

Education / Experience Requirements

• Degree in an engineering/quality or related discipline
• Certified QE desirable
• Technical report writing
• Process validations/FMEA's and protocols

Specialized Skills / Other Requirements

• A seasoned, experienced professional with a full working knowledge of EN ISO 13485 the principles of GMP % FDA QSR 21 CFR Part 820
• Proficient in 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

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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 [e-mail].

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.