Our client, a medical device company in Galway are currently looking to recruit a Senior Quality Engineer
for their site.
- 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
The Ideal Candidate
- 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 analyse 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.
For further information on this Senior Quality Engineer role in Galway please contact Orla on 086 0449473 / firstname.lastname@example.org
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