Quality Systems Engineer II
Area Medical Devices
An exciting Quality System Engineer role is now available in a progressive Medical Device company in Galway, excellent package and benefits including 4 day working week.
- Implement and maintain the Quality System in compliance with ISO 13485 /MDD & relevant QSR requirements.
- Develop the Quality System to meet the needs of the EU Medical Device Regulation 2017/745
- Lead the implementation of Key quality systems which support the business NCR, CAPA and Deviations
- Coordinate and lead site internal auditing program.
- Facilitate all Notified Body inspections and audits
- Facilitate Senior Management review of the Quality System through metric generation and review.
- Preparation and maintenance of documentation in compliance with the appropriate regulatory requirements
- Support the Operations team as required
- Support Corporate Quality Management System objectives
- Act as complaint coordinator
Qualifications & Competencies
- An Engineering or Quality Assurance Degree or equivalent experience.
- A minimum of 3 years post qualification experience as a Quality Systems Engineer within a Medical Device or regulated environment.
- Demonstrable detailed working knowledge of the medical device industry.
- An analytical approach to problem solving.
- A self-starter that applies their own initiative in most situations.
- A good team player, who works well in a small team environment, must be able to work effectively with peers in other Departments.
- Capacity to make sound judgements while learning from mistakes.
- Knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements.
- Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
- Displays the highest levels of integrity.
Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role.
Contact Joan O’Malley at for more details.