Senior Quality Engineer

Aurora Lifesciences; Yorkshire, Northern (VA, KY); Sur place; USD 95 000 - 125 000; Plein temps

Résumé du poste

Aurora Lifesciences is seeking a Senior Quality Engineer to own quality activities in a regulated manufacturing environment. You will support ISO 13485 QMS implementation, perform internal audits, drive CAPA and root-cause investigations, and collaborate with Production, Engineering and Supply Chain to improve quality across the business.

You will work on reviewing drawings and inspection reports, managing non-conformances, and analysing data to identify risks and opportunities for sustainable

Qualifications

• Strong practical knowledge of ISO 13485.
• Experience implementing or improving a Quality Management System.
• Experience planning, conducting and following up ISO 13485 internal audits.
• Experience supporting external, customer or regulatory audits.
• Proven experience managing CAPA, non-conformances and root cause investigations.
• Ability to use structured root cause tools (5 Whys, Fishbone).
• Experience leading quality or process improvement projects.
• Ability to interpret engineering drawings and inspection reports.

Responsabilités

• Own and drive ISO 13485 QMS implementation, development and maintenance.
• Lead and support internal audits and ensure corrective actions close.
• Support customer, supplier and regulatory audits.
• Lead quality improvement projects from problem to implementation.
• Investigate manufacturing and product issues and drive root cause resolution.
• Manage non-conformances, CAPA, deviations and concessions to closure.
• Review engineering drawings, specifications and inspection requirements.
• Oversee product and batch release activities and document traceability.
• Analyse quality data and KPIs to identify risks and improvement opportunities.

Connaissances

ISO 13485 knowledge

Root cause analysis

CAPA management

Quality data analysis

Auditing

Outils

CMM reports review

Dimensional inspection techniques

Description du poste

We’re looking for an experienced Senior Quality Engineer who wants to take real ownership of quality within a growing precision manufacturing environment.

This is a hands-on role where you’ll work closely with Production, Engineering, Inspection and Supply Chain, but you’ll also have the opportunity to influence how quality operates across the wider business.

As a Senior Quality Engineer, you’ll play a key role in supporting the implementation and ongoing development of the Quality Management System, ensuring it meets ISO 13485 requirements and works effectively in practice.

You’ll be someone who is comfortable moving between the shop floor and the QMS – solving immediate manufacturing issues while also leading longer-term quality projects and improvements.

The Role

You’ll take ownership of a broad range of quality activities, including:

• Supporting the implementation, development and maintenance of an ISO 13485 Quality Management System.
• Leading and supporting internal audits against ISO 13485 and ensuring actions are driven through to completion.
• Supporting customer, supplier and regulatory audits.
• Leading quality improvement projects from initial problem through to implementation and review.
• Investigating manufacturing and product issues and leading structured root cause investigations.
• Managing non-conformances, CAPA, deviations and concessions through to effective closure.
• Making informed product disposition and quality decisions.
• Working with Production and Engineering to identify root cause and introduce sustainable corrective actions.
• Reviewing engineering drawings, specifications and inspection requirements.
• Reviewing dimensional inspection results, including CMM reports.
• Supporting incoming inspection and supplier quality activities.
• Overseeing product and batch release activities.
• Ensuring documentation, records and product traceability remain accurate and audit-ready.
• Analysing quality data, trends and KPIs to identify risks and improvement opportunities.
• Developing and improving procedures, work instructions and quality processes.
• Coaching and supporting colleagues on quality processes, problem-solving and QMS requirements.

You’ll already have solid experience working within quality in a regulated manufacturing environment and be ready to take greater ownership of projects, systems and improvements.

For this Senior Quality Engineer position, we’d like you to have:

• Strong practical knowledge of ISO 13485.
• Experience implementing, developing or significantly improving a Quality Management System.
• Good experience planning, conducting and following up ISO 13485 internal audits.
• Experience supporting external, customer or regulatory audits.
• Proven experience managing CAPA, non-conformances and root cause investigations.
• Confidence using structured root cause tools such as 5 Whys and Fishbone.
• Experience leading quality, process improvement or corrective action projects.
• The ability to interpret engineering drawings and technical specifications.
• A good understanding of dimensional inspection and manufacturing measurement techniques.
• Experience reviewing CMM and other inspection reports.
• Knowledge of product release, batch release, traceability, concessions and deviations.
• Experience working with suppliers to resolve quality and documentation issues.
• Strong data analysis, reporting and quality KPI experience.

Experience within medical device manufacturing or another ISO 13485 regulated environment would be particularly valuable.

The Person

This role will suit a Senior Quality Engineer who enjoys taking ownership rather than simply highlighting problems.

You’ll be confident leading investigations, getting to the root cause of issues and bringing different teams together to deliver a solution. You’ll also be comfortable challenging existing processes when something could be done better.

You don’t need to be someone who wants to sit behind a QMS all day. We’re looking for somebody who can be visible within manufacturing, understand what is happening at the point of inspection and production, and then use that knowledge to improve the wider quality system.

You’ll be able to lead projects, manage priorities independently and communicate effectively with people at all levels of the business.

Ultimately, success in this Senior Quality Engineer role will mean helping build a stronger quality culture, supporting a robust ISO 13485 QMS and making sure improvements are practical, measurable and sustainable.