I am seeking Quality Engineers based in Dublin and surrounds to join a large Medical Device company. This is an excellent opportunity to join a leader in their field on a permanent basis.
The ideal candidate will have a background in the Medical device or Pharmaceutical industry paired with a minimum 4 years relevant experience. An in-depth knowledge of ISO 13485, CFR 11820 and ISO 14971 a must. An excellent understanding of CAPAs, change control and non conformances is essential and knowledge of Minitab also desirable. A Level 8 degree in a Science, Engineering or Technical discipline essential.
Oversee daily quality operations regarding conforming products for manufacturing and completing root cause analysis of non conformances to efficiently close them out.
Adhere to compliance of quality system requirements in line with procedures regarding FDA quality system regulations, ISO 13485 and any international and national standards.
Lead risk assessments and risk control cross functionally.
Support development and validation of inspection/test methods.
Looking after pre production quality assurance activities across operations, engineering and validations.
Define product and process validation requirements, protocols and approvals.
Assist in internal and external audits.
If this role is of interest to you, please 'Apply Now'.
For more information on this role and a confidential discussion please contact Aoife O'Driscoll, QA, and Validation Specialist Recruitment Consultant @ Morgan McKinley 021 2300 300 / firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.