Design Assurance Engineer – Developed Start-up
- Act as a key person within the DA function, advising on new technology and breakthroughs in the MedTech sector in regulations and standards.
- Work cross functionally, performing project management as needed, with the other functions providing support in relation to DA, specifically specification development and design development.
- Provide guidance in relation to development of protocols, reports, procedures, deviations and change requests daily.
- Work on and develop design verification and validation plans, protocols, risk assessments and reports.
- Will Co-ordinate the design history file for designated projects and helping with compliance projects and documentation.
- Support ISO inspections and registrations while also ensuring the quality policy and company systems and procedures are complied with.
- Lead internal audits and review change controls and complete qualification for NPD and NPI projects.
- Engineering degree with 5 years’ experience in a pharmaceutical or medical device environment.
- Must have 5 years in a Quality or DA function in a medical device company or a high level of understanding of design assurance, six sigma or design for manufacturing.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.