Quality Engineer

We're looking for a Quality Engineer to join a leading Medical Device Organisation in Cork. This is a long term 18 month hourly rate contract position.

Key Responsibilities;

• Drive and implement process improvements to ensure predictable processes across all product lines (e.g risk reduction, yield improvement, error proofing , cost reduction initiatives, process automation activities)
• Provide effective and response QA support to operations to meet their areas objective of quality cost and output.
• Ensure all process variables and their interactions are adequately defined, Ensure all failure modes in process have been identify and addressed (e.g Use of DOE studies, FMEAs)
• Drive and implement plant wide quality systems improvements
• Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g FDA and TUV)
• Management of incoming inspection area to ensure efficient supply to production areas
• Provide function expertise to other support functions on quality related issues (e.g regulator requirements. Statistical techniques sampling principles)
• Approval of change requests for process and quality systems changes
• Compilation of required regulatory documentation (e.g technical files , design dossiers product transfer lines essential requirements)
• Participate in internat quality audits
• Support the implementation of Lean Manufacturing across the site

Education and Experience

• Minimum of bachelors of science degrees in engineering / technology
• 2-3 years experience in a manufacturing environment or equivalent with direction experience in a QA environment (preferable GMP regulated)
• Experience in the Medical device industry is an advantage.