Competitive Salary, dependent on experience, and company share options.
BIOS is unlocking the potential of the nervous system in treating chronic disease by using AI-powered neural interfaces that can automatically read and write neural signals. The human nervous system carries vast quantities of data and scientists have long known that faulty signals in the nervous system play a key role in driving chronic diseases. By understanding and correcting these signals in real time, BIOS can treat chronic illnesses in an effective, automated, and personalised way, leading to seamlessly experienced healthcare.
BIOS are looking for a Quality Manager to guide their medical device developments. This role will focus on device development and regulatory submission and certification, providing strategies for driving product quality and continuous improvement.
Main duties and responsibilities:
- Liaising and co-operating with Certification and Notified Bodies, working with external consultants as required.
- QMS documentation and development, ensuring the QMS meets the current needs of the business, in line with industry standards and accreditation requirements.
- Managing internal, external and supplier audits e.g. recruiting and training of internal auditors.
- Working with Engineering and other teams to ensure compliance with design and change control processes, providing QA oversight to development projects.
- Supporting device development activities such as compiling and managing technical files.
- Developing risk management plans and activities.
- Establishing and managing the quality processes, e.g. change control, CAPA, document control, supplier evaluation, post-market surveillance.
- Preparing for and supporting clinical trial submissions.
- Quality training throughout the business including inductions, QMS, quality processes, standards, regulations etc.
- Responsible for ensuring that any changes to standards or regulations are identified and communicated in a timely manner.
- Primary interface for external auditors and regulatory agencies for on-site audits and follow-up.