Aurora Lifesciences
Quality System Engineer
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If you’re a Quality Engineer who believes quality should be visible on the manufacturing floor rather than managed purely from behind a desk, this role offers the opportunity to make a genuine impact.
You’ll help develop, measure and continually improve the QMS, working closely with Manufacturing, Quality and wider technical teams to ensure processes remain effective, compliant and practical. This is a hands-on position within a regulated medical device environment, with a strong emphasis on ISO 13485.
The role would suit someone who enjoys challenging existing processes, using data to understand where improvements are needed and building a quality-first mentality across the organisation.
The Role
You’ll take an active role in improving the QMS, identifying trends, managing quality issues and ensuring improvements translate into stronger manufacturing performance.
Key Responsibilities
- Own and analyse QMS performance metrics, using meaningful data and trends to identify risks, weaknesses and improvement opportunities.
- Drive continuous improvement across the QMS, developing quality plans and improvement projects where processes are underperforming.
- Lead and support NCR investigations, ensuring non-conformances are appropriately investigated, documented and dispositioned.
- Determine when issues require escalation into CAPA, supporting robust root cause investigation, corrective action and effectiveness monitoring.
- Use risk-based decision making aligned with ISO 14971 (ISO14971) when assessing product, process and manufacturing quality issues.
- Conduct and support internal, supplier and external audits, ensuring findings are effectively addressed through the QMS.
- Review quality trends and provide clear, evidence-based information to leadership on risks and required actions.
- Deliver training across the QMS, helping Manufacturing and cross-functional teams understand quality processes and expectations.
- Act as an on-floor Quality Engineering contact, providing practical guidance on deviations, documentation, inspection issues and non-conforming material.
- Support NCR, MRB and production investigations, working directly with Manufacturing to resolve issues at source.
- Review production deviations and changes, assessing their impact on product quality and regulatory compliance.
- Support production-related validation activities including process, equipment and software validation where applicable.
- Author and improve procedures, work instructions and quality documentation in accordance with ISO 13485 requirements.
- Support CAPA and root cause activities arising from recurring manufacturing issues, audit findings or negative quality trends.
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You’ll ideally bring 3–5+ years of Quality Engineering or Quality Systems experience within medical devices or another highly regulated manufacturing environment.
You should have practical knowledge of ISO 13485, experience managing NCR and CAPA activities, an understanding of ISO14971, and confidence using data to support quality decisions.
Most importantly, you’ll be someone who is comfortable getting onto the manufacturing floor, asking the right questions and taking ownership of improvement.
If you have a passion for quality, enjoy improving a QMS and believe strong quality systems should help manufacturing perform better rather than simply create more paperwork, this role provides the opportunity to make that difference.
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