High performance hardware and software product design and manufacturer requires a Production Quality Manager. My client?s 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, FMEA?s, BS EN ISO 14971:2021 also BS EN ISO 9001:2015 and 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 CAPA?s
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 company?s 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.