ISO 14971, ISO 13485, FDA regulations, FMEA, RCA, Medical Devices, Validation, Quality controlHigh performance hardware and software product design and manufacturer requires a Production Quality Manager. My clients networked smart devices are used by engineering and medical industries for Computer Vision, motion capture, robotics, virtual and augmented reality applications. As the Production Quality Manager, you will be responsible for implementing, maintaining, and delivering company quality and compliance also with all group companies towards common quality and compliance policies. The successful candidate will have over four years leadership experience in a QA, Quality or Compliance role within a Software, Hardware and/or firmware device manufacturing organisation. Responsibilities Risk Management and Compliance, FMEAs, BS EN ISO 14971:2021 also BS EN ISO 9001:2015 & BS EN ISO 13485:2016. Support of internal records relating to compliance and quality throughout the design, production and manufacturing process. Exception documents, such as Non-Conformances and CAPAs Customer audits as well as auditing key suppliers and supplier visits. Own continuous Compliance Improvements throughout. Quality Management, capability of product sampling procedures. Quality Manuals, procedures and related documentation. Validation and Verification documentation and testing reports. Ensure new product developments are documented through the companys Project Management System and internal Change Control Process. Liaison with cross functional departments regarding compliance issues with products such as Research and Development Hardware and Software, Manufacturing and Supply Chain. Investigation and Root Cause Analysis into customer returns.