Senior Quality Engineer

About us 52North is a medical technology company on a mission to make emergency care safer and more effective. Awarded breakthrough status for its first product Neutrocheck® by the UK Government in 2024, we build innovative diagnostic and digital solutions to transform patients' journeys in emergency care. Our mission-driven team of scientists, engineers, clinicians, and designers is backed by leading UK and US hospital venture funds, Meridian Health Ventures and Cedars-Sinai Intellectual Property company, and other partners, including the University of Cambridge and Macmillan Cancer Support.

About the role This role is an exciting opportunity to join a fast-paced company and to be part of building on and developing the quality framework. The role is a critical member of the Quality and Regulatory (QA/RA) function, taking responsibility for the quality management system, supplier quality management and the project quality activities. The role will cover the full product lifecycle and will include aspects of software as a medical device. Note that this is a hybrid position requiring you to be in our Cambridge office at least two days a week, with Tuesday as the Company’s anchor day.

What you will do:

• Responsible for the design, creation, implementation and maintenance of the Quality Management System (QMS) in line with company objectives (including software development processes).
• Contribute to QMS process improvements and promote a culture of compliance and quality within the company.
• Plan and execute internal and external audits, with action plans.
• Establish metrics for monitoring QMS adequacy and effectiveness.
• Own the quality aspects of supplier management, working cross functionally to assess and approve suppliers and manage the supplier quality relationships.
• Plan and execute supplier audits and track audit findings and actions.
• Escalate any significant risks or overdue actions to the Head of QA/RA.
• Own the change control, non-conformances and CAPAs system and governance, working cross functionally to ensure the processes are effective and efficient.
• Establish metrics for company reporting as a health check for these processes.
• Responsible for QMS aspect of Management Reviews, including preparing data input and presenting to the leadership team.
• Identify QMS scope expansion activities driven by the company and programme objectives, align these with the head of QA/RA and take ownership of execution.
• Act as Deputy Quality Management Representative (QMR), supporting the Head of QARA in ensuring QMS compliance.
• Oversee administration of accurate QMS records and documentation in line with company procedures.
• Responsible for supporting project teams with Quality aspects of product and digital development activities throughout product lifecycle.
• Author/review/consult on and approve project documentation according to QMS.
• Partner with regulatory peers to ensure regulatory activities and quality activities are aligned and provide input to the regulatory documentation / strategy.

Other duties as may be required by the business from time to time.

What we need:

• Degree in scientific, engineering or another relevant discipline.
• At least 8 years’ experience working in an ISO13485-certified quality management system for devices that require review and approval by authorities (e.g. FDA, Notified Body, UK Approved Bodies).
• Experience in building, implementing and managing an ISO 13485 and US FDA CFR 820/QMSR quality system(s).
• Experience in Design Control and Risk Management (ISO 14971) implementation.
• Experience in conducting/leading internal and external audits and in hosting audits from customers/regulatory bodies.
• Experience in representing quality on complex medical device/IVD/SaMD design and development.
• Excellent attention to detail, organisational, team-working, influencing and communication skills.
• Critical and proactive thinker, able to work in a fast paced, flexible environment.

Even better if…

• Experience working with In Vitro Diagnostics.
• Experience working with ‘Software as a Medical Device’ products and/or connected devices.
• Experience working effectively within smaller organisations.

What can you expect from us:

• A competitive benefits package that includes private medical and dental insurance and a contributory pension scheme.
• Equity, letting you share in 52North’s long-term success.
• 28 days annual leave plus bank holidays and enhanced maternity leave.
• A diverse and inclusive work environment that brings together multidisciplinary experts in many fields, including scientists, engineers, clinicians and designers.

How to apply:

Please send a CV and covering letter to careers@52north.health. Your covering letter should explain why you are applying for the job and what skills and experience you can bring to the role. We review CVs as we receive them and interview as soon as we have applications that look like a good match (usually within one week). We do not use closing dates. So, please apply as soon as possible to avoid missing out on this role.

Everyone is welcome at 52North. We are an equal opportunities employer and encourage applications from eligible and suitably qualified candidates regardless of age, disability, ethnicity, gender, gender reassignment, religion or belief, sexual orientation, marital or civil partnership status, or pregnancy and maternity/paternity.

If you need any adjustments made to the application or selection process so you can do your best, please let us know. We are happy to help.