A Technology Transfer Engineer is required by CareerWise Recruitment for our Cork based client.
This Engineer has an opportunity to join a multi national medical device company.
This is an intital 12 month contract role.
Role of this position
- Represent Quality as part of a cross functional team to ensure delivery of projects (NPI's and Technology) into production with the highest level of quality, compliance, and adherence to timelines
- Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
- Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production
- Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
- Liase with R&D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development
- Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce human error.
- Lead QA input to Design for Manufacture activities on site.
- Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR's and ISO 13485/9001 requirements etc.
- A degree level or similar qualification in mechanical or industrial engineering.
- Minimum 1 year of experience in a quality role within a regulated industry.
- Proven ability to successfully introduce new product development in the Medical Device Industry.
- Proven knowledge and ability regarding product verification and process validations.
- Proven knowledge of FDA and MDD GMP requirements regarding medical devices.
Please call Mike Donovan today for further information on 021-2061901 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)