Senior Quality Engineer Job at Life Science Talent (Cambridge)

Senior Quality Engineer

Life Science Talent

Location:
United Kingdom , Cambridge

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

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.

Job Responsibility:

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

Requirements:

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

Nice to have:

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 we offer:

Private medical and dental insurance
Contributory pension scheme
Equity
28 days annual leave plus bank holidays
Enhanced maternity leave
Diverse and inclusive work environment

Additional Information:

Job Posted:
May 03, 2026

Employment Type:

Fulltime

Work Type:

Hybrid work

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