Sr. Quality Engineer, Quality Systems

Teleflex Incorporated; Leinster; Hybrid; EUR 75,000 - 110,000; Full time

Job summary

Teleflex Incorporated in Ireland (Leinster) is seeking a Quality Systems professional to strengthen compliance with ISO 13485 and EU‑MDR across the QMS. The role emphasizes internal audits, CAPA, training, and continued improvement.

You will collaborate with R&D, RA, supplier quality, and manufacturing to ensure regulatory alignment, coordinate external audits with Notified Bodies, and lead regional quality initiatives. Travel up to 10% and hybrid work options available.

Qualifications

• Engineering/Science degree essential.
• Medical device experience essential.
• 5/7 years in a quality environment essential.
• Lead Quality Auditor Certification essential.
• Excellent technical writing skills essential.
• Attention to detail and accuracy essential.
• Ability to work well under deadlines and pressure.
• Strong communication and problem-solving abilities.

Responsibilities

• Quality System compliance to ISO 13485, MDD, EU-MDR, MDSAP and regulatory requirements for QMS.
• Support global quality processes: Change Management, Training, NC, CAPA, QDAR, Auditing, Management Review.
• Coordinate and support Internal Audit program and ensure timely completion of audits.
• Generate, interpret, analyse and communicate results using management tools and reports.
• Conduct Internal Audits per audit schedules and participate in external audits with Notified Bodies/ authorities.
• Provide Quality Systems support to all areas of the QMS (PMS, RA, R&D, Supplier Quality, Customer Services, Marketing Communications).
• Project manage Quality System related initiatives and drive regional quality improvements.
• Delegate for Manager Quality Systems during planned/unplanned leave.

Skills

Excellent communication

Problem solving

Attention to detail

Technical writing

Project coordination

Education

Engineering/Science degree

Tools

MS Office

Job description

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.

Expected Travel

Up to 10%

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).

Principal Responsibilities

• Quality System compliance to ISO 13485, MDD, EU‑MDR, MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the QMS.
• Support the implementation of Teleflex global quality system processes, including but not limited to Change Management, Training, NC, CAPA, QDAR, Auditing, and Management Review.
• Coordinate and support the Internal Audit program. Promote effective and timely completion of audits to ensure compliance to audit schedules.
• Generate, interpret, analyse, and communicate results using management tools, graphs, and reports.
• Conduct Internal Audits per relevant audit schedules.
• Coordinate, support and participate in external audits (including audit facing Quality System Lead when required) with Notified Bodies/ and other government agencies.
• 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
• Delegate / Designate for Manager Quality Systems / Management Representative when required during planned and unplanned leave.

Education / Experience Requirements

• Engineering/Science degree/qualification – essential
• Medical Device experience – essential
• 5/7 years of working within a Quality environment – essential
• Lead Quality Auditor Certification – essential
• Excellent technical writing skills – essential
• Attention to detail and accuracy – essential
• Ability to work well under deadlines and pressure
• Communication skills
• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MS Project, Outlook, and Excel)
• Excellent analytical ability
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management

Specialized Skills / Other Requirements

• Self-driven and ability to work independently and/or as a team player
• Approachable and enthusiastic. Flexible and adaptable
• Good organisational skills with cultural awareness and sensitivity
• Good judgement and problem‑solving ability and is capable of understanding the impact of decision making on both Teleflex Medical and its customers
• Strong collaboration and influencing skills – both internally and externally
• Excellent communication skills – both written and verbal
• Goal orientated for customer and business objectives
• Coaching/mentoring skills

Travel Required

5 %

Working Environment

Office/Professional (Hybrid)

Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.

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.