Posted Mar 20 2019
UK or US Remote
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The Quality Manager is a critical role for our growth. This role will take responsibility in maintaining and enhancing our operational and quality systems to ensure compliance with our internal and external regulatory standards. You will be involved in every stage of the product life cycle and its deployment having a crucial input in building the best possible product that saves people’s lives.
It is expected that the person in this role will utilise their expertise to guide our team in interpreting policies and regulations assure compliance by default. You will help the team prepare reports and documentation ensuring the Quality Management System is kept up to date and in line with product developments. The role will take the lead on audits and inspection preparation, ensure successful resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
• Act as a leader of global quality, influencing a “Quality By Default” culture and owning our Quality Management System (QMS).
• Development and maintenance of the QMS that meets Regulatory and business expectations for physical medical devices and software as a medical device.
• Augment and improve the QMS to reflect both best practices and internal development process.
• Maintain our organisational knowledge of laws and regulations, provide oversight of current and evolving regulatory requirements to ensure the QMS remains current.
• Be an active participant in the product development lifecycle, advising on quality management requirements and ensuring these developments are supported by the QMS.
• Establish and improve product lifecycle processes to ensure quality is maintained at the heart of our development strategy.
• Perform internal audits and assessments as applicable. Ensure readiness for and hosting Notified Body audits.
• Maintaining documentation such as design dossiers, technical files and Declarations of Conformity.
• Evaluating and monitoring sub-contractor compliance and maintaining Technical Agreements as appropriate.