Senior Quality Engineer - Medical Devices - Galway IRE

€ 1 - 1 Per year
Full time
Job level
Qualified (non-manager)
12 Jan 2020
10 Jul 2020

Job Description

A Major Global Medical Devices Company in Galway, Ireland wish to recruit a suitably qualified person for the following post:


The Respiratory, Gastrointestinal, and Informatics business (RGI) within the Minimally Invasive Therapies Group at the Galway site manufactures respiratory care and patient monitoring devices.


* Define, implement and maintain and improve Quality System requirements in the form of Quality Assurance
* Supervise personnel within an area of the Quality Department. Take the lead in this area.
* Develop and modify Procedures and other related procedures
* Participate/support the Management Review Process
* Provide reports/information to management on quality related issues and define and implement solutions to quality related issues
* Participate in and lead cross-functional teams as directed by the Quality Manager
* Participate in and lead internal/external audits as required
* Ensure that product conforms to specification and control further processing, delivery on installation or non-conforming product until the deficiency or unsatisfactory condition has been corrected
* Ensure that preventive and corrective actions are taken in relation to product and Quality system deficiencies and initiate, recommend or provide solutions to product and Quality system related problems
* Interface with other departments to ensure that Quality system requirements are adhered to
* Participate in and initiate job-related training courses
* Follow all environmental, health & safety rules and procedures and participate in safety and environmental activities in order to improve the workplace for all employees


* BEng/BSc Level 8 degree qualified with at least 5-7 years' experience in a manufacturing organization
* Medical Device/Healthcare Industry experience is desirable
* Excellent working knowledge of Quality System Requirements within the Medical Device/Healthcare industry
* Knowledge of FDA and ISO compliance
* Must be capable of carrying out documentation related responsibilities as well as technical responsibilities
* Ability to work well as part of team and also to lead a team
* Strong communication, organizational and project planning skills.
* Ability to write engineering documents, test protocols, FMEAs
* Skilled in statistical methods (Hypothesis testing, SPC, sampling plans, Gage R&R, process capability and graphical analysis).
* Able to analyze and chart data using MS Excel or Minitab
* Previous Quality Auditor experience is desirable, or certification is an advantage
* Experience in Design Quality is desirable.


Excellent Salary/Benefits package on offer

For immediate interview, please email your CV to


For informal enquiries, please telephone Christy on Applyor Applycrvdbrcktso if outside Ireland)


Ref: NET - 174868

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This job was posted to Biomedical in Galway

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