|Kenny-Whelan & Associates
SENIOR QUALITY ENGINEER
4 - 5 Years
Shane O Mahony
A Quality Engineer is required for a company based in Galway
Within this position you will be responsible for:
The role would consist of directing a team of 4 Quality Engineers and a team of 5 Quality Technicians.
The role operates in a Finished Goods Catheter Manufacturing Area
13 Finished Goods Product Families. Weekly output of approx 13-14,000 units per week.
Responsibilities consists of dealing with day to day issues as they arise within the Manufacturing Environment to assure product Quality is maintained at all times with regard to outgoing product quality and on line quality assurance.
The ability to work in a regulated environment is essential as is a minimum of 7 years Medical Device experience in a Quality Role with at least 2 years prior experience in a senior role.
A demonstrated ability to manage a team of people.
An ability to prioritise work and to deal with issues in a sound and efficient manner.
Experience of working within CAPA and Lower Level Feeder Systems (NCM, MRR etc) is essential.
A working knowledge of Process Change Requirements, Process Validation and Risk Management Techniques is also required.
Audit experience of executing Internal Audits, and -presenting to External Auditors (FDA, TuV, NSAI etc) would be a distinct advantage.
For further information on this position or similar roles please contact me on 021 4665404