Technology Transfer Engineer
The successful candidate will lead the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and company R&D personnel ensuring timely communication to all stake holders to effect successful project completion.
MAIN DUTIES & 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.
*Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR's and ISO 13485/9001 requirements etc. during all day to day
*Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
*Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap, and reprocessing.
*Assist in the development, review, and approve product, gauge, tooling and fixturing drawings.
*Maintain a good level of housekeeping in designated areas and observe all Health and Safety at work requirements.
*To adhere to the company's procedures as detailed in the CSOP manual.
Qualifications & Experience:
*A degree level or similar qualification.
*Minimum 1 years' 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.
*Proven experience and training in Mechanical Engineering processes.
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.