Our client, a medical device company in Leitrim are currently looking to recruit a Process Engineer for their site.
- Development & maintenance of process & tooling including providing specifications and procedures in accordance with the requirements of ISO 13485 (2003) & MEDDEV 93/42/EEC.
- Ensuring that the necessary testing, evaluation & control of equipment measures are in place to monitor & support product quality in accordance with the requirements of ISO 13485 (2003) & MEDDEV 93/42/EEC.
- Ensuring that new product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 (2003) & MEDDEV 93/42/EEC. Identifying and specifying materials, processes, tooling and equipment for new products. Organising and/or completing IQ?s, OQ?s and PQ?s and ensuring validations are completed prior to production.
- Problem solving and trouble shooting on Non-conforming materials, customer complaints and incapable processes.
- Ensuring that Processes are set up and monitored according to work instructions. Training of Technicians and Operators as required.
- Participation in On-going Process Improvements.
- Participation in the development of plant lay-outs, material travel & handling & over-all work plan in order to provide effective synchronous manufacturing.
- Ensuring that that non-conforming product and processes are evaluated and corrected as required in accordance with process controls and production procedures. Participation in the MRB Programme & product disposition
- Participation in plant Corrective/ Preventive & Continuous Process Improvement programmes.
- Participation in the Internal Quality Audit Programme & Vendor Audit Programme.
- Participation in the Internal Validation Programme & ensuring that all new processes are validated before transfer to production.
- Maintenance and upgrades on facilities, AHU, Chillers, Boilers, Buildings, grounds, Clean rooms, etc...
- Ensuring Preventative Maintenance and other maintenance activities are completed to schedule.
- Troubleshooting/correcting equipment breakdown in a timely manner.
- Third level Qualification in Engineering or Science, preferably in Mechanical or Medical.
- Ideally 2-3 yr. previous experience in a Medical Devices / HealthCare Environment.
For further information on this Process Engineer role in Leitrim please contact Anna McGowan on 091730022 / email@example.com
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