Sr. Quality Systems Engineer

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Date: Oct 18, 2024

Location: Athlone, L, IE

Company: Teleflex

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.

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 maintenance and continuous improvement of the ISO 13485 quality management system processes.
  • 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
  • CAPA Leader who develops and designs corrective actions for known problems using established problem-solving tools and techniques
  • Coordinate, support and participate in external audits (including audit facing Quality System Lead when required) with Notified Bodies/ and other government agencies
  • Prepare and deliver training and orientations on global quality system requirements and company processes to employees.
  • 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 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

Behaviours / Values:

  • 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

#LI-Hybrid #LI-ND1

 

 

 

 

 

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.   
If you require accommodation and support to apply for a position, please contact us at talent.emea@teleflex.com.
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™, 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. 
© 2024 Teleflex Incorporated. All rights reserved.