This best-in-class multinational medical device company have a fantastic reputation at national and international level. This company champion the full life cycle of innovative and leading-edge technologies from concept design to market release, and are an employer of choice within Limerick, with an exceptional employee satisfaction ranking.
This aspect of the Quality function is focussed on investigating and problem-solving incoming complaints. You will work closely with various medical device products and work closely with many other departments, including the Design, R&D, Sustaining, Manufacturing, Quality, Product Management and Regulatory teams!
- 2 – 4 days work from home per week – number of days is completely up to you!
- Investigating customer complaints – conducting root cause analysis and problem solving
- Interdepartmental team working
- Conducting risk assessments on incoming complaints
- Authoring and reviewing technical documentation
- Supporting the CAPA and NCR programmes
- Providing complaint information to the Post Market Surveillance (PMS) team
- 3rd level qualification within a relevant discipline.
- Ideally, 6 months + experience working within the Quality department of the medical device or pharmaceutical Industry.
- Excellent organisational skills and an ability to multitask within a busy, high-volume manufacturing environment.
- High level attention to detail
- Excellent technical writing skills
Nice to have
- Knowledge and experience (ideally 6 months+) of working with ISO13485, ISO14971, MDD, EU-MDR and FDA regulations.
- Strong industry experience of authoring Quality / Regulatory documentation
- Strong experience in technical writing
- Industry-leading base salary
- Hybrid WFH Model – you can work from home 4 days/week!
- Flexible Working Hours
- Bonus , paid quarterly
- Private Medical Insurance for you and your family
- Pension contributions
- Gym, Educational Assistance, S&S and more!
Full job description available on request.
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