12-Month Fixed Term Contract (view to permanency)
The purpose of this job function is to engage in the day-to-day manufacturing of medical devices. This will involve the tasks outlined in the Main Duties and Responsibilities below while playing a supporting role to other groups such as R&D and other areas in the company.
The Production Operator will work as part of the Operations Team in the development and manufacture of innovative medical devices in accordance with the requirements of International Standards: ISO 13485, the FDA Code of Federal Regulations 21 CFR Part 820, Medical Device Directives 93/42/EEC and 2007/47/EC and the Companies Medical Quality Management System.
Main Duties & Responsibilities
Build sub-assemblies and finished devices, including packaging for testing, clinical investigations, and commercial release.
Complete part and subassembly visual and dimensional inspection activities in line with documented procedures and standards.
Responsible for issuing materials to the manufacturing line and setting up equipment & fixtures on the manufacturing line.
Assist with the management of the Material Control System, including incoming inspections, part issuance and tracking.
Participate in training activities and become proficient in the required manufacturing and inspection activities in a timely manner.
Assist in the preparation and execution of "in process" device testing and recording of associated results.
Identify and communicate opportunities for improvement in product quality and throughput and participate in the successful implementation of the same.
Provide training and guidance to team members on building, inspection and testing of products.
Ensure full compliance with released Work Instructions and Procedures.
Complete written and soft-copy quality records in line with GDP requirements.
Be dependable in coming to work, adhering to work and break schedules, and meeting required quality and productivity standards.
Trades or third-level academic qualifications preferred.
Leaving Certificate or equivalent minimum.
Minimum of 4 years of medical device manufacturing experience (at least 2 years of which were cleanroom-based).
Demonstrated experience with GDP & GMP standards is advantageous.
Work Experience/Training Provided
For a confidential discussion and more information on the role, please contact Emma Daly.