Our client, a medical device manufacturer are seeking a Senior Quality Engineer to join their operations in Galway on a 1 year contract basis. The Senior Quality Engineer will play a key role in the planning and execution of all quality activities related to new product introductions, technology transfers, manufacturing and the Novate Quality System. The person will work closely with the Galway team /key local and international sub-contracting manufacturing facilities.
• Provide Quality Engineering support through the entire Product Development process, understanding Design Assurance activities, reviewing associated documents including Design Verification/Design Validation, Design and Process FMEA, Process Validation and Test Summaries.
• Work as part of the team including support to the process/product being transferred from a technical and quality viewpoint and to understand and define the Process FMEA, Process Validation Requirements (including OQ / PQ / PPQ) and Quality Plans for the transferred process.
• Review all validation processes and documentation at sub-contract manufacturing facilities.
• Support of the Internal Audits, Vendor Audits and Regulatory Agency audits.
• Ensure that in Quality issues are effectively prioritised and acted upon in a timely manner.
• Degree in Science/Engineering/technology with 5+ years experience in a similar role within the Medical Devices or related industry (Hons degree an advantage).
• Good knowledge of ISO 13485 and FDA quality requirements.
• Flexibility essential with strong project management skills.
• Strong communication & organizational skills.
• Strong understanding of validation concepts, planning methods and documentation.
• Excellent attention to detail and report-writing ability.
• Proven ability to work on own initiative.
• Highly organized with strong ability to prioritize tasks.
• Experience of statistical analysis methods and their application to QC activities, testing and validations is a distinct advantage.
If you would like further Information you can contact the recruiter directly:
Oran McIvor | Tel: +353 (0) 1 507 9270