Description
Are you a entrepreneurial quality engineer that likes a a challenge? My Client a innovative Start up medical device company based in Waterford is seeking a quality engineer.The Quality engineer will take responsibility for the running and continuous improvement of the company's ISO 13485:2003 quality system and ensure that all projects, processes and procedures are fully compliant with this system so that our customers worldwide equate FastForm Research, its products and brands with Premium
Quality Management Responsibilities:
-Maintenance and control of Quality System
-Scheduling and chairing of Quality Management Review meetings (biannual) issuance and control of minutes for same
-Issuance of KPI data for the company quality System: monthly graphical & tabular data detailing the following activities:
-DCN's raised and closed out
-CAPA's raised and closed out
-Internal audits done
-PO's raised and closed out
-Execution of Internal Quality Audits, issuance of audit reports
-Raising of Corrective and Preventative Actions, completion of all activities required to close CAPA's out including vigilance inspections over given periods of time to ensure corrective/preventative actions are effective
Other areas of responsibility will include Product Development,Quality Activity,Vendor Control,Documentation Control, training,Maintenance and Calibration and Control of customer feedback/device vigilance.
Minimum experience and requirements: Over 3 years experience in a quality systems role working to ISO 13485:2003 standards in a Healthcare/Medical Device environment plus experience in Document Control and Quality assurance. Experience in Design & Development activities under ISO 13485:2003 is a distinct advantage.
If you are interested in this great opportunity and have the relevant skill s and experience please contact me Anna Mooney or apply below with an upto date CV . An attractive salary and benefits package is on offer for more details get in touch.
To find out more about Real please visit www.realstaffing.com