* 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.
* 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 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 approval of product, gauge, tooling and fixture drawings.
* A degree level or similar qualification in mechanical or industrial engineering.
* Minimum 5 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
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