Here at Volpara, were on a mission to save families from cancer. By combining our ground-breaking Breast Health Platform with empowered patients, we are unleashing a revolution in cancer detection. You can check out more about what we do here: https://youtu.

be/YoWsuV64uAI?si=iqzcN7PAiXoogwSg If you want to find out more about this fantastic opportunity to join our growing company making big changes in the world, read on! What you'll be doing: The Head of Quality Affairs is accountable for maintaining and improving Volparas medical device quality management system and ensuring its ongoing certification, whilst adopting an efficient approach for the organisation that achieves its key objectives. This involves a proactive, forward-looking assessment of potential risks and issues, with ongoing reviews of current operations. Ensure the Quality Management system (QMS) is developed and maintained in compliance with ISO 13485.

This includes ensuring all processes and procedures are documented, controlled and effectively implemented and records are maintained in line with regulatory requirements. Ensure the QMS complies with all relevant statutory and regulatory requirements from applicable global markets, including the USA, Europe, UK, Australia, Canada and Japan. This includes medical device regulations and other regulations (e.

g., AI & privacy) that impact the QMS. Ensure the QMS is right sized to meet internal stakeholder needs, balancing risk as required, to maintain an efficient but operationally effective QMS.

Lead continuous improvement initiatives to enhance QMS operational efficiency and product quality, and safety. Acts as the safety risk manager for Volpara medical device products, ensuring compliance with the medical device safety risk standard, ISO 14971 for pre and post market activities. Acts as the Management Representative to meet our regulatory obligations and communicating with internal stakeholders through preparing and presenting Management Reviews.

Communicate with external stakeholders as required, including external auditors, regulators and QMS suppliers. Lead, mentor and develop the Quality Affairs team, fostering a culture of quality and continuous improvement and promoting values in line with the company culture code. Provide guidance and training to other functions to ensure legislative and compliance responsibilities are met, and internal controls are maintained.

Ensure management and staff are suitably equipped to cope with the growing complexity of software medical device product development globally. Oversee the quality and security internal audit function and ensure audits are performed as planned. This may be through internal and/or external resources or providers.

Participate in change management reviews to ensure quality systems are not adversely impacted. Participate actively in operational management activities as needed (e.g.

budgeting, staffing, etc.). What you'll bring to the role: 8-10 years broad operational man.