The job holder will participate in 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.
- 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 utilize DFMEA/PFMEA and other QA risk analysis techniques in order to minimize potential risk during development/implementation activity.
- Liaise 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 the 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 a 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.
Degree level or similar qualification in mechanical or industrial engineering.
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