Senior Technical Quality Lead — Medical Devices

Aurora Lifesciences; West Yorkshire; On-site; GBP 70,000 - 100,000; Full time

Job summary

Aurora Lifesciences is seeking a Technical Quality Lead to act as the quality authority across product development, manufacturing and the Quality Management System. This senior individual contributor role focuses on technical leadership rather than pure people management, with involvement across engineering, manufacturing, and quality teams.

You will ensure new and existing products and processes are developed, validated and maintained to regulatory standards, driving robust change control, CAPA

Qualifications

• Significant Quality Engineering experience in medical device or regulated tech sectors.
• Strong background with new product development.
• Degree in engineering, biomedical or related technical field, or equivalent experience.
• Solid knowledge of ISO 13485, ISO 14971, 21 CFR 820 and EU MDR.
• Hands-on with design controls and design verification/validation.
• Experience supporting manufacturing environments.
• Understanding of process validation and equipment qualification.
• Experience with non-conformance investigations, root cause analysis and CAPA.
• Ability to review and approve technical documentation and engineering changes.
• Strong analytical, statistical and risk-management capabilities.

Responsibilities

• Act as the senior Quality Engineering representative across NPD and technical projects.
• Provide technical quality leadership through product development, validation and manufacturing.
• Review and approve design, process and product changes.
• Partner with Engineering and Manufacturing to develop robust processes.
• Lead design verification/validation activities and validation planning.
• Support design control documentation and change control.
• Investigate complex non-conformances using root cause analysis.
• Develop and oversee corrective and preventive actions.
• Guide process validation, equipment qualification, IQ/OQ/PQ activities.
• Support sustaining engineering, process monitoring and supplier quality.

Skills

Quality engineering

ISO 13485

Design controls

Root cause analysis

CAPA

Process validation

Equipment qualification

Risk management

Statistical analysis

Stakeholder management

Education

Engineering/biomedical degree

Equivalent industry experience

Tools

IQ/OQ/PQ documentation

Job description

Aurora Lifesciences is seeking a Technical Quality Lead to act as the quality authority across product development, manufacturing and the Quality Management System. This senior individual contributor role focuses on technical leadership rather than pure people management, with involvement across engineering, manufacturing, and quality teams.

You will ensure new and existing products and processes are developed, validated and maintained to regulatory standards, driving robust change control, CAPA