The opportunity to join a global medical device manufacturer of Haematological IVD devices based close to Dublin, Ireland. You will join as a Quality Engineer ensuring all aspects of reagent manufacturing systems are maintained in compliance to company Quality systems and regulations.
- Promote Quality System usage to avoid product field actions or major non-compliance in external audits.
- Ensure non- conforming equipment, suppliers, manufacturing activities are noted and addressed to ensure product safety and effectiveness.
- Ensure participation in the CAPA management across the full product life cycle inclusive of involvement in the complaints process.
- Assist product and process changes to maintain to regulatory guidelines.
- Maintain and update reagent and instrument risk management files as required.
- Cross-functional support across R&D, Supply Chain, Marketing and Technical support.
- Degree or equivalent in life sciences.
- 2+ years experience working within the medical device industry (IVD desirable).
- Experience working with haemostasis/haematology (desirable).
- Fluency in English.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.