Technical Quality Lead – Afternoon Shift

Aurora Lifesciences; Yorkshire, Northern (VA, KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Aurora Lifesciences seeks a Technical Quality Lead to act as the quality authority across product development, manufacturing and the Quality Management System.

This senior, hands-on role emphasizes technical leadership over people management, collaborating with Engineering, Manufacturing and Quality to ensure design controls, risk management and regulatory compliance are embedded throughout the product lifecycle.

Qualifications

• Significant Quality Engineering experience in medical devices or regulated tech
• Experience with new product development (NPD)
• Deep knowledge of ISO 13485, ISO 14971, 21 CFR 820 and EU MDR
• Hands-on design controls and design verification/validation
• Experience with manufacturing environments and process validation

Responsibilities

• Act as 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 manufacturing processes.
• Lead or direct design verification and validation activities.
• Support development and implementation of design control documentation.
• Investigate non-conformances using root cause analysis and CAPA.
• Develop and oversee corrective and preventive actions.
• Provide guidance on process validation and equipment qualification (IQ/OQ/PQ).
• Support sustaining engineering, process monitoring, change control and disposition of non-conforming material.
• Own or act as SME for key elements of the Quality Management System.
• Apply risk management throughout development and manufacturing.
• Support internal audits, supplier quality activities and regulatory inspections.
• Provide input into post-market quality and product performance.
• Coach and mentor Quality Engineers and technical colleagues.
• Translate complex quality information to technical and non-technical stakeholders.

Skills

Quality Engineering

New product dev

Regulatory compliance

Root cause analysis

CAPA

Process validation

Equipment qualification

Risk management

Documentation review

Stakeholder management

Education

Engineering degree

Job description

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.