Posted on Oct 26, 2021 by CV-Library
Countless opportunities to learn new skills through coaching, mentoring and formal training
Numerous health and wellbeing initiativesGlobal medical imaging brand, based in Oxford (or remote) Their mission is to equip clinicians and healthcare professionals with the world's best medical imaging and AI-powered automation.
As a key member of the QARA team, you will maintain the QMS to meet applicable regulations, actively guiding internal and external audits, documenting and resolving non-conformities.
You will support the project development teams to ensure that products are manufactured to the required standards for numerous countries, including reviewing design and development documentation and authoring product regulatory and quality documentation.
*Maintain the ISO 13485-certified Quality Management System
*Ensure all procedures are up to date with changing standards and regulations and are being implemented by all employees.
*Facilitate notified body audits, supplier audits, and internal audits
*Conduct supplier quality assessments and maintain approval records
*Investigate and document resolutions to any identified non-conformities
*Review product documentation for design and development projects to ensure process compliance and compile Technical Documentation files and other regulatory documentation
*Coordinate changes to processes and associated staff training
SKILLS AND EXPERIENCE
*Knowledge of quality standards including ISO 13485 and ISO 14971
*Experience of taking a key role: developing quality processes and driving process improvement
*External and internal audit experience, including hosting notified body audits, and conducting supplier quality assessments
*Understanding of the EU Medical Device Regulations (MDR)
*Knowledge of MDSAP regulations
*Knowledge of quality standards including IEC 62304 and IEC 62366 and ISO 19011
*Knowledge of other global regulatory frameworks
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