Job Description
The Technology Transfer Engineer will report to the QA Technical Leader and lead from a Quality Technology Transfer Engineering perspective.
Responsibilities:
* Document and maintain all relevant Quality assurance sections of Device.
* Provide QA input for URS for new technology/equipment.
* Liase with R & D to ensure CTQs are agreed and documented for all NPD.
* Lead Design for Inspection activities for all NPD to reduce human factors.
* Lead QA input in Design for Manufacture activities on site.
* Ensure correct use of statistical QA methods in the production environment.
* Provide technical resource for the production team on IQ/OQ/PQ protocol issues.
* Ensure compliance with all documented Quality systems.
* Provide technical assistance to carry out problem analysis/complaint investigation.
* Assist in problem solving in established production processes.
* Monitor and establish scrap and reprocessing rates for all NPD.
* Review and approve product, gauge, tooling, and fixturing drawings.
* Operate within the company's standard operating procedures.
Qualifications & Experience:
* A degree level or similar qualification in mechanical or industrial engineering.
* Proven ability to successfully introduce new product development in the Medical Device Industry.