We’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance.
Responsibilities may include the following and other duties may be assigned.
• Performs a variety of duties in the electronic, mechanical, electromechanical, and/or optical areas.
• Constructs, troubleshoots, calibrates, adjusts, tests, diagnoses, and maintains equipment, components, devices, or systems.
• Works from schematics, engineering drawings and written or verbal instructions.
• Operates related equipment; conducts tests and reports data in prescribed format.
• Performs calibration and alignment checks; makes adjustments, modifications, and replacements as directed; prepares prescribed compounds and solutions.
• Performs co-ordination and data entry activities for product returned for analysis as part of the Complaint Handling Process including product receipt, traceability and archiving of all devices received as per regulatory requirements.
• Perform daily monitoring of chemicals and maintenance of chemical solutions for the decontamination process. Perform initial analysis and decontamination of returned devices.
• Perform product analysis and investigations including review of manufacturing documentation and the documentation of investigation results for complaint files as appropriate. And lead or support root cause investigations; drive problem solving efforts to support complaint file completion.
• Ensure timely completion of assigned activities to meet Customer needs, departmental goals and regulatory reporting requirements
• Lead or participate in COS and A3 activities in support of Cell Deployment activities in the PXM Department.
Education & Experience
•We are looking for a qualified person to diploma level (Level 7 NFQ minimum) in a relevant Engineering or Science discipline and preferably with 1-2 years relevant experience in an operations or laboratory medical device or related environment.
•Experience/understanding of complaint handling or CAPA processes are desirable. Candidates must be able to think critically and make sound decisions.
If you would like further Information you can contact the recruiter directly:
Jack Caffrey | Tel: +353 (0) 1 507 9279