A Quality Engineer is required by CareerWise Recruitment for an Athlone based medical device company on a 18 month contract basis. The Quality Engineer will be directly involved in understanding and providing compliance solutions and documentation throughout the project lifecycle, designed to continuously improve manufacturing processes, systems, quality and regulatory compliance to the highest standards.
Role of this position
- Key contributor and team player in the provision of Quality assurance and compliance to engineering projects and services.
- Plan and execute validation IQ, OQ & PQ protocols and reports to FDA requirements.
- Co-ordinate the completion of risk management, process capability and statistical assessments and will provide quality engineering support to resolve process problems.
- Write, review and update compliance documents, procedures, protocols, reports and relevant documents required in the course of achieving Quality compliance.
- Third level degree in a relevant Quality/Engineering/Science related discipline.
- 3-4 years Quality Engineering experience in a medical device environment or similar highly regulated environment.
- Knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies.
- Knowledge, understanding and implementation of GAMP5 is also an advantage.
Please contact Michelle Galvin today for further information on 091 373938 / email@example.com
CareerWise Recruitment (In Search of Excellence)