Job Description
A SENIOR DESIGN QUALITY ENGINEER is required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime, hybrid role on an initial 9-month contract. The SENIOR DESIGN QUALITY ENGINEER will provide QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs.
Role of this position
1. Responsible for ensuring Design control and Risk Management activities
2. Provide Quality support/guidance to R&D projects leads/team members.
3. Provide direction and support to Design Assurance engineers and Quality Engineers.
4. Co-ordinate the Design Assurance Engineer resources to support business objectives.
5. Resolve project issues by working with team members, suppliers, and others as appropriate.
6. Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
7. Manage and maintain the records related to design control projects.
8. Contribute and participate in design review meetings.
JOB REQUIREMENTS
9. Bachelors Degree (Level 8) in Engineering, Biomedical Engineering, Science, or related discipline.
10. 5+ years' experience in a similar role.
11. Demonstrated knowledge of the application of the principles, concepts and practices of design control, sterilization and Quality Assurance processes.
12. Experience in preparation, participation and response to external agency inspections e.g. FDA and Notified Body Inspections