A Senior Quality Engineer is required by CareerWise Recruitment for our Galway based client. Excellent working knowledge of Quality System Requirements within the Medical Device/Healthcare industry, as well as knowledge of FDA and ISO compliance is a major requirement of this role. Please contact Tom Devaney for more information.
* Define, implement and maintain and improve Quality System requirements in the form of Quality Assurance
* Supervise personnel within an area of the Quality Department and 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 Assurance Quality is desirable.
Please call Tom Devaney today for further information on 091-758771 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.