Senior Technical Quality Leader for Medical Devices

Aurora Lifesciences; West Yorkshire; In loco; GBP 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Aurora Lifesciences is seeking a Senior Technical Quality Lead to act as the technical quality authority across product development, manufacturing and quality systems. The role focuses on embedding quality throughout the lifecycle, solving complex engineering challenges and guiding cross-functional teams.

The ideal candidate brings significant medical device quality engineering experience, hands-on design controls, and a track record of leading stringent regulatory compliance across development

Competenze

• Significant Quality Engineering experience in medical devices or regulated tech.
• Strong experience with new product development.
• Hands-on knowledge of regulatory standards and design controls.
• Solid understanding of ISO 13485, ISO 14971, 21 CFR 820 and EU MDR.
• Experience in manufacturing environments and process validation.

Mansioni

• Act as the senior Quality Engineering representative across new product development and technical projects.
• Provide technical quality leadership through product development, validation, transfer and manufacturing.
• Critically review and approve design, process and product changes.
• Partner with Engineering and Manufacturing to develop robust processes.
• Lead design verification/validation activities and design control documentation.
• Investigate complex non-conformances using root cause analysis and CAPA.
• Oversee corrective/preventive actions and risk management.

Conoscenze

Quality Engineering experience

New product development

Regulatory compliance knowledge

Formazione

Engineering/biomedical/technical degree

Descrizione del lavoro

Aurora Lifesciences is seeking a Senior Technical Quality Lead to act as the technical quality authority across product development, manufacturing and quality systems. The role focuses on embedding quality throughout the lifecycle, solving complex engineering challenges and guiding cross-functional teams.

The ideal candidate brings significant medical device quality engineering experience, hands-on design controls, and a track record of leading stringent regulatory compliance across development