We are currently looking for Quality Engineers in the Waterford / Wexford areas.
Main responsibilities involve:
- Ensure compliance to quality system requirements including FDA QSR, ISO 13485 and applicable standards (e.g. EN, ASTM)
- Ensure continuous material compliance and timely disposition of non-conforming materials.
- Perform supplier audits and surveillance
- Apply risk management, change control, and validation principles throughout the product lifecycle
- Investigate and document customer complaints and apply root cause analysis and problem-solving techniques.
- Develop risk assessments and risk controls and implement corrective/preventive actions.
- Third level qualification in either a Science, Engineering or Technical related field.
- At least 1 year of relevant experience in pharma or med devices industries
- Strong ISO 13485 and regulatory requirements knowledge.
Interested? For immediate consideration, please call Greg on 051-878813 or email your CV in response to this job posting.
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