Quality Engineer

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.

Responsibilities

• 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.

Qualifications

• 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.
• 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.

Benefits

• 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.

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