This world leading, innovative organisation provide design and contract manufacturing solutions for the medical devices market. They have a diverse client portfolio, from large multinational companies to startups. With a reputation for being an innovative market driver in medtech solutions, they are now looking for a Quality Engineer to join their team on their Galway site.
You as the Quality Engineer will act as a key contributor to the effective collaboration between the product engineering, manufacturing and quality functions; providing specialist expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls and Risk Management particularly around technology transfer
- Understand the requirements of Design Control and facilitate design review
- Provide Quality/Engineering support with a focus on Process validation to the design and transfer into manufacturing
- Preparing/Reviewing Master Validation Plans, Design specifications, and risk management documentation.
- Work within project teams to establish process controls that ensure the product is manufactured in a compliant manner.
- Providing ongoing communication, and documentation to the design and technology transfer teams to ensure compliance with design control documentation.
- Ongoing monitoring of the company’s quality objectives and performance
- Collaborate with the operations function to help facilitate the successful execution of the new product/project development
- Work closely with Quality Management, assisting in the continuous development of the QMS.
- Engage early in the product development cycle with validation engineers
- Degree in Quality, Engineering or related.
- At least 5 years in Quality/GMP environment in the Medical Device industry.
- Good knowledge of Design Control and validation required.
- High level of interpersonal communication and organisational skills
- Ability to take initiative, influence cross-culturally and functionally, organise and priorities own work and to actively contribute to project level
To discover more about this opportunity, apply now or contact Orla Boyle at HRM Recruit on +353 91 782110 for a confidential discussion.
Salary: On Application