Our client, a medical device company in Galway is currently looking to recruit a Quality Engineer for their site.
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 meetings.
- Provide Quality/Engineering support with a focus on Process validation to the design and transfer into manufacturing team.
- 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 metrics.
- Collaborate with the operations function to help facilitate the successful execution of the new product/project development project.
- Work closely with Quality Management, assisting in continuous development of the QMS.
- Engage early in the product development cycle with validation engineers.
Education & Experience
- Degree in Quality, Engineering or equivalent.
- 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 organizational skills required.
- Ability to take initiative, influence cross-culturally and functionally, organise and priorities own work and to actively contribute to project level planning.
For further information on this Quality Engineer role in Galway please contact Orla on 086 0449473/ Talent@hero.ie
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