This is an immediate vacancy for an experienced Quality Engineer for a medical device company based in the Galway area.
Duties & Responsibilities include but are not limited to:
- Provide day to day quality support to the manufacturing and engineering teams.
- Manage CAPA, NC's and Customer Complaints.
- 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
- Participate in Root Cause Analysis.
- Provide reports/information to management on quality related issues and implement solutions to quality related issues
- Participate in internal/external audits as required
- Carry out metrology activities, relating to drawings, measurements, geometrical dimensions and tolerances
- Interface with other departments to ensure that Quality system requirements are adhered to
- Follow all environmental, health & safety rules and procedures and participate in safety and environmental activities in order to improve the workplace for all employees
Education & Experience Required:
- Degree in Quality or Degree in Science / Engineering.
- 5+yrs industry experience in a Medical Device-manufacturing or Pharmaceutical environment.
- Working knowledge of FDA/ISO Quality systems for Medical Device companies.
- New product introduction and manufacturing process transfer experience would be a distinct advantage.
- Good working knowledge of Quality System Requirements within the Medical Device Industry - ISO13485:2016 & FDA
- Quality auditor experience/certification
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.