As part of our clients plans for growth, they are looking for a Quality Assurance Engineer. Your role will be to support the Quality Manager in ensuring that all product released by for human use meets the Company’s product quality requirements, and to ensure that product is manufactured, released and distributed in accordance with the regulatory requirements outlined below.
• Support the finished device manufacturing subcontractor and suppliers to ensure that the company's product quality and regulatory requirements are met.
• Perform lot review and lot release activities.
• Support the operations group to ensure that product manufacture and release activities meet business needs.
• Review and contribute to process validation and risk management activities of the subcontractor and supplier.
• Support Operations, subcontractors and suppliers in implementing process improvement and lean initiatives.
Education & Training
Educated to a Minimum Diploma Level in an Engineering, Science or Quality Assurance discipline.
Auditing Qualifications are desirable.
A minimum of 3 years’ manufacturing quality or quality systems experience is required, ideally in a Medical Device manufacturing environment
Experience of managing relationships with subcontractors and suppliers is preferred.
Experience in performing process validation and risk management activities is required.
Excellent attention to detail, communication skills, project management skills, people and team working skills.
Excellent problem-solving skills
Experience in ISO standards and Quality Management Systems.
CAPA, Auditing and Risk Management experience
If you would like further Information you can contact the recruiter directly:
Kevin Silke | Tel: +353 (0) 1 507 9255