Do you have 3+ years of Quality experience working within Medical Devices? Do you have experience within a production environment as well as managing customer complaints? Then please read on!
My client is one of the leading Medical Devices company’s that are based in Waterford, and they are looking for an experienced Validation & Quality Engineer to join their expanding team.
- Create concise & accurate technical reports and clearly report communicate these results internally & to customers through quality tools & statistical techniques.
- Monitor performance through e.g. SPC, CP, R&R analysis etc.
- Act as customer conduit for all quality-related issues.
- Drive quality improvements.
- Gather and analyse data, determine root cause using e.g CAPA, 8D etc.
- Ensure effective CAPA management.
- Conduct validation activities.
- Lead internal risk assessment (FMEA).
- Develop Validation documentation.
- Document management for suppliers, validation protocols and reports. Assist in training materials for qualification activities.
- L8 in the relevant qualification
- Experience working within Medical Devices- ISO 9001-13485 CFR 820 knowledge.
- Validation of manufacturing & clean room
- 3+ years’ experience within a quality department
- Experience in a production environment
- Customer complaints experience
For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@Sigmar.ie
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