The Freudenberg Group, a global technology group with 48,000 employees in some 60 countries, develops leading-edge technologies, and excellent products, solutions and services for more than 30 market segments. Freudenberg & Co. Kommanditgesellschaft, with its Headquarter in Weinheim, is the strategic parent company of the broadly diversified Group. Freudenberg Medical is a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.

Medical Device - Quality Assurance Engineer
Open to other industry experience

Your tasks

  • Integration & Maintenance of the Quality Management System with all VISTAMED processes in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC.
  • Deputising for the Management Representative in their absence.
  • Provision of support to all departments to ensure that products manufactured meet customer requirements.
  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC.
  • Review and Release of batch paperwork for Product release.
  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845.  Generation of Product Technical Files & associated studies in accordance with MEDDEV 93/42/EEC when appropriate.
  • Maintenance of the Customer Complaint investigation process, MEDDEV  93/42/EEC vigilance requirements and assisting in product recalls & corrective/ preventive action programme.
  • Participation in routine Failure Investigation & process trouble-shooting.
  • Maintenance of plant Trending & Continuous process improvement programmes.
  • Participation in the Plant Corrective Action Programme.
  • Participation in the Internal Quality Audit Programme.
  • Co-ordination & maintenance of the Calibration Programme.
  • Co-ordination & maintenance of the Validation Programme.
  • Maintenance of the Plant Environmental & Cleaning/ Housekeeping Programme, including sub-contractor maintenance.
  • Maintenance of the Plant Laundry & Rodent Control Sub-Contractors to required standards.
  • Vendor Assessment liaison & Maintenance.
  • Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer.


Our expectations

  • Third level qualification in Engineering/Manufacturing/Quality with emphasis on Medical Device/Biomedical.
  • 2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical environment.
  • Fully PC literate.

Preferred Qualifications

  • Minitab experience.

Freudenberg Medical is a global partner for the design, development, and manufacture of innovative medical device technologies.  We offer the following services to medical device, pharmaceutical and IVD clients worldwide - product design and development, silicone and thermoplastic moulding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer that medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Freudenberg Medical maintains design and manufacturing centres in California, Indiana, Massachusetts, Minnesota, Costa Rica, Europe and Asia. 

VistaMed, a Freudenberg Medical Joint Venture Company are a leading provider of complex extrusions, finished catheters and devices to the minimally invasive medical device industry. We are a “one stop shop” solution for the Design, Manufacture, Assembly, Sterilisation and Distribution of Catheters. VistaMed’s Culture is positive and very team orientated. In our workplace environment, we are enthusiastic about helping others with our innovative medical devices. Our Company is very driven to be a leader in the Medical Device sector, and always eager to improve the quality of life in the patients in which we serve.

VistaMed is a local, innovative, high growth company with a collaborative, high performance work environment. Our highly talented teams of committed employees enable us to be the best, remain leaders in our field, and deliver first-class service to our clients. We understand that our team drive the company and therefore we are committed to ensuring personal development, safety, happiness and prosperity for all our employees.

Location: Carrick-on-Shannon, Co. Leitrim, Ireland

We are currently hiring a QA Engineer:

  • Self-motivated, thrives in a fast-paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
  • Strong interpersonal and communications skills.
  • Ability to manage multiple tasks and adapt in a challenging, fast paced environment.

It’s an exciting time to work in VistaMed. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus benefits. Learn more at or

Freudenberg Medical and VistaMed are an equal opportunity/affirmative action employer

Do you have any questions?

Freudenberg Medical - VistaMed
Eithne Ní Bhrádaigh ∙ Human Resources ∙ IDA Business and Technology Park ∙ N41 N8C9 Carrick-on-Shannon, Co. Leitrim, Ireland ∙
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