About Your New Employer
You will work for a medical device company based in Galway’s med-tech hub, working closely with both the Quality and R&D teams. You will be responsible for Design Assurance, Design Control and Risk Management Activities.
About Your New Job
As a Design Assurance Engineer, you will…
- Prepare and execute (in conjunction with the design teams) design verification and validation plans, protocols and reports ensuring design documentation meets the company and regulatory requirements.
- Oversee and manage testing completed both in-house and by external test houses on behalf of Vivasure, ensuring compliance with test protocols and all regulatory standards.
- Report, analyse, and make appropriate recommendations from test results or other process related findings.
- Analyse test data to establish performance standards for newly implemented or modified products/processes.
- Generate quality and technical documentation to support design activities and quality system requirements including maintenance of Design History Files.
- Identify, design and implement test fixturing to support data generation and Design Verification testing.
- Lead design teams on the preparation of risk analysis and essential requirements assessments.
- Support the Product Realisation Teams as new products are developed and launched onto the market.
- Lead and own ERs and CAPAs as designated, driving root cause investigations and corrective actions for design assurance issues.
- Support the continuous improvement of quality system processes and the overall business.
What Skills You Need
- Bachelor’s Degree Science, Quality, Engineering, Manufacturing or related field experience
- Minimum 3 years in a Quality Role in a medical device environment (Design Assurance experience a significant advantage).
- Knowledge of risk management activities – EN ISO14971
- Product and process validation experience.
- Working knowledge of FDA QSR and EN ISO13485.
What’s on Offer
- Permanent Position
- Health Insurance for you and dependents
- Up to 3% pension contribution
- 10% Bonus
What’s Next
Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306
Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.
