Technical Quality Lead - Afternoon Shift

Aurora Lifesciences; West Yorkshire; Presencial; GBP 90 000 - 120 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Quality Engineering experience

New product development

Regulatory compliance knowledge

Formação académica

Engineering/biomedical/technical degree

Descrição da oferta de emprego

We are supporting a growing medical technology organisation in the appointment of a Technical Quality Lead to take a highly influential role across product development, manufacturing and the wider Quality Management System.

This is a senior individual contributor position for someone who enjoys being the technical quality authority within a business rather than moving away from engineering into pure people management.

You will work across Engineering, Manufacturing, Quality and other technical functions, helping ensure new and existing products, processes and design changes are developed, validated and maintained to the appropriate regulatory and quality standards.

The role offers significant visibility across the organisation and would particularly suit somebody who enjoys solving complex technical problems, challenging engineering decisions constructively and improving how quality is embedded throughout the product lifecycle.

What You’ll Be Doing

As Technical Quality Lead, you will:

• Act as the senior Quality Engineering representative across new product development and technical projects.
• Provide technical quality leadership throughout product development, validation, transfer and commercial manufacturing.
• Critically review and approve design, process and product changes.
• Partner with Engineering and Manufacturing teams to develop and validate robust manufacturing processes.
• Lead or provide technical direction for design verification and validation activities.
• Support the development, review and implementation of design control documentation.
• Investigate complex product and process non-conformances using structured root cause analysis.
• Develop and oversee effective corrective and preventive actions.
• Provide technical guidance around process validation, equipment qualification and IQ/OQ/PQ activities.
• Support sustaining engineering, process monitoring, change control and non-conforming material disposition.
• Own or act as SME for key elements of the Quality Management System.
• Apply strong risk management principles throughout development and manufacturing.
• Support internal audits, supplier quality activities and regulatory inspections where required.
• Provide technical input into post-market quality activities and product performance.
• Coach and mentor Quality Engineers and other technical colleagues.
• Translate complex quality and engineering information clearly to both technical and non-technical stakeholders.

What We’re Looking For

This position is aimed at an experienced Quality Engineer who has developed beyond transactional quality activities and can operate as a genuine technical partner to Engineering and Manufacturing.

Ideally, you will bring:

• Significant Quality Engineering experience within the medical device or closely regulated technology sector.
• Strong experience supporting new product development.
• A relevant engineering, biomedical or technical degree, or equivalent industry experience.
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR 820 and EU MDR.
• Hands-on experience with design controls and design verification/validation.
• Experience supporting manufacturing and production environments.
• Strong understanding of process validation and equipment qualification.
• Experience with non-conformance investigation, root cause analysis and CAPA.
• Confidence reviewing and approving technical documentation and engineering changes.
• Strong statistical, analytical and risk-management capability.
• The ability to work effectively across multidisciplinary teams.
• Strong communication and stakeholder-management skills.

The Person

This is likely to appeal to somebody who is hands-on, technically credible and comfortable challenging the status quo.

You may currently be operating as a Quality Manager, Principal Quality Engineer, Lead Quality Engineer, Senior Quality Engineer or Technical Quality SME and looking for an opportunity where your technical judgement will have genuine influence.

You do not necessarily need to be looking for a traditional management position. The emphasis is on technical leadership, engineering credibility, problem solving and the ability to raise the standard of Quality Engineering across the organisation.