QA Engineer – Validation
Location: Carrick-on-Shannon, Co. Leitrim, Ireland
We are currently hiring a QA Engineer (Validation):
- Self-motivated, thrives in a fast-paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
- Strong interpersonal and communications skills.
- Ability to manage multiple tasks and adapt in a challenging, fast paced environment.
- Your tasks
- Ensuring product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MDD 93/42/EEC.
- Participation in new product introduction programmes, to ensure effectively introduced in accordance with the requirements of ISO 13845.
- Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC, when appropriate.
- Validation Programme completion – Risk Analysis, VMP, IQ’s, OQ’s, PQ’s as required according to procedure QAP 030 and other related procedures
- Level 8 degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical.
- 2-3 yrs previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment.
- Fully PC literate.
- Minitab experience.
For more information contact Sean on 094 90 29944