Quality Manager

The Quality Assurance and Regulatory Affairs (QARA) department supports the company at a corporate level and regionally in both the UK and the US. With the support of the Senior Management Team and Board of Directors, the QARA department ensures that the company complies with regulatory requirements in all applicable global regions and supports the company to meet the required quality standards and objectives in all areas of the business. The Quality Manager will report to the Head of the QARA Team.

The main duties and responsibilities of the role are

• Maintaining the MDSAP and 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.


• Supporting the management of the Information Security Management System alongside the Information Security Officer (as per ISO 27001).


• Facilitate management reviews, 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.


• Leading, supporting and coaching Mirada QA team.


• Deputising for and supporting other QARA team members as required.
  
  Do you want to work somewhere with real purpose in life saving technologies? Are you a Quality Assurance manager with a keen interest in healthcare and have experience with software as a medical device?


Mirada is looking for a driven and detail oriented Quality Manager to join the team!,
• Prior experience of working for a small to medium-sized medical device company in quality or compliance-based role.


• Experience with software as a medical device or medical device with software and knowledge of Medical Device Regulations (EU MDR, US CFR 21 Part 820 and/or other global medical device regulations).


• External and internal audit experience, including hosting notified body audits, and conducting supplier quality assessments.


• Experience of taking a key role within a quality regulated environment, developing quality processes and driving process improvement.


• Knowledge of quality standards including ISO 13485 and ISO 14971


• Experience of establishing company quality objectives


• Excellent communication and interpersonal skills


• Strong leadership and decision-making abilities


• Strong analytical and problem-solving skills


• Excellent organisational and task management skills


• Superb attention to detail


• Ability to work efficiently and meet deadlines in a fast-paced environment.


Advantageous


• Qualification in regulatory affairs or quality assurance


• Knowledge of MDSAP regulations


• Knowledge of quality standards including IEC 62304 and IEC 62366 and ISO 19011


• Knowledge of other global regulatory frameworks


• Experience of process improvement


• Proven track record of successful project management.
  
  Mirada Medical develops medical imaging and cancer treatment planning solutions that provide simple and accessible solutions to complex image analysis problems in the diagnosis and treatment of cancer and other diseases. Our solutions interoperate with other IT systems in the healthcare enterprise, such as EHRs and PACS, empowering users to access our clinical solutions when and where appropriate and to exchange data. Our treatment planning solutions improve consistency and productivity while enabling clinicians to deliver more personalised care. By combining deep learning technology with our thorough understanding of the challenges faced in oncology today, Mirada is leading the development of next generation imaging software and decision support products. Our staff are passionate about using their expertise to help our customers provide better healthcare for more patients., Why work for Mirada?



• Our hybrid working model means this is a great opportunity for anyone who wants to have a mixture of office work and working from home.


• We are a socially impactful company. At Mirada, you will see how the products you help to create impact those helping to fight cancer.


• We are a company that is proud of people's careers and want to give you the skills to progress and grow. We offer countless opportunities to learn new skills through coaching, mentoring and formal training.


• We actively emphasise the importance of a good work-life balance, as such we are a company that can flex to the commitments you have outside of work.


• We are a company that actively promotes wellbeing and champions a stigma-free environment. With numerous health and wellbeing initiatives, everyone at Mirada has the help and support to thrive both at work and away from work.