Headcount Solutions is a leading provider of specialist resourcing needs both nationally and internationally. One of our Medical Device manufacturing clients has an urgent requirement for a Supplier Quality & Development Engineer.

The successful candidate will possess strong Engineering and Project Management experience along with working knowledge of Quality Engineering principles, tools, and practices.

Principal Responsibilities:

• Drive supplier capacity and quality improvements for purchased products by increasing supplier and internal competencies in process control / verification and validation studies, root cause analysis, failure mode and effects analysis (FMEA), and the use of Process Excellence tools.
• Work with NPD groups in leading the supply chain related capacity and logistics initiatives, and quality engineering activities, in developing and reviewing product design and test protocols.
• Provide general engineering support to in-coming inspection on specific projects.

Requirements:

• BSc in an engineering discipline.
• Minimum 4 years relevant experience in a similar role
• Experience in the validation of special processes such as heat treatment ovens and terminal sterilization.
• Strong engineering skills with working knowledge of the following:
- Process validation and verification activities. (IQ, OQ, PQ, PPQ)
- Risk analysis techniques, including FMEA.
- Manufacturing Control Plans and Flow Plans.
- Measurement System Evaluation.
- Process Capability Analysis.
- Problem solving techniques including root cause analysis, and cause and effect analysis.
• Strong knowledge of Quality Regulations ISO9001:2000, ISO13485:2003, FDA CFR Part 820, FDA CFR Part 211
• Demonstrated Process Control application with Six Sigma certification preferred.

For further information, please contact Michael McQuade on 01-6905040 / 086-0435195 or submit cv in strictest confidence to jobs@headcount.ie