LSC have a great contract opportunity for a Senior Tech Transfer Engineer to join a multinational medical device company based in Cork.
If you have minimum 5 years experience in a quality role within a regulated industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A degree level or similar qualification in mechanical or industrial engineering.
- 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.
- Proven experience and training in Mechanical Engineering processes.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Conor Dolan at LSC on 021-4777329 if you have anymore questions about this Senior Tech Transfer Engineer opportunity!