JOB PURPOSE:
Reporting to the QE Leader Leader the Quality Engineer shall lead from a Quality perspective.
The job holder will lead the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and 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 house-keeping in designated areas, and observe all Health and Safety at work requirements.
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.
#CplCorkEng
