Senior Quality Engineer - Med Device, Growth & Impact

Aurora Lifesciences; South Yorkshire; Presencial; GBP 55 000 - 75 000; Tempo integral

Resumo da oferta

Aurora Lifesciences in the United Kingdom is seeking a Senior Quality Engineer to strengthen its growing medical device operation. You will provide hands-on quality engineering across manufacturing, validation, design changes and quality systems.

You will influence how Quality Engineering operates as the site scales, lead improvement projects and mentor others, while ensuring compliance with 21 CFR Part 820, ISO 14971 and risk management throughout the manufacturing lifecycle.

Qualificações

• 4+ years' Quality Engineering experience within medical devices.
• Familiarity with 21 CFR Part 820 / FDA Quality System requirements.
• Good understanding of ISO 14971 and medical device risk management.
• Experience with CAPA and corrective/preventive action implementation.
• Practical experience of IQ/OQ/PQ and process validation.
• Experience producing and reviewing validation protocols, technical reports and Quality documentation.
• Experience with internal and/or supplier auditing.

Responsabilidades

• Develop, optimise and qualify manufacturing processes with Manufacturing Engineering.
• Support and approve engineering and design changes.
• Provide QA input into new processes, procedures and equipment.
• Create, review and approve IQ/OQ/PQ validation protocols and reports.
• Support the Validation Master Plan.
• Support design verification and validation activities.
• Lead process validation, equipment qualification and Gage R&R.
• Review manufacturing docs to ensure regulatory and Quality compliance.
• Lead risk management activities including Process FMEA.
• Identify and lead continuous improvement and process optimisation initiatives.
• Conduct manufacturing floor audits and ensure procedures are followed.
• Plan and perform internal and supplier audits.
• Support equipment maintenance, calibration and preventative maintenance.
• Lead investigations into non-conformances.
• Drive root cause analysis and corrective actions.
• Support NCRs, CAPAs, complaints and post-market quality activities.
• Mentor less experienced Quality Engineers.
• Take ownership of QA projects for manufacturing growth.

Conhecimentos

Quality Engineering

Medical devices

CAPA

IQ/OQ/PQ

Process Validation

Root Cause Analysis

Risk Management

Auditing

Formação académica

Bachelor's degree in Engineering or Science

Descrição da oferta de emprego

Aurora Lifesciences in the United Kingdom is seeking a Senior Quality Engineer to strengthen its growing medical device operation. You will provide hands-on quality engineering across manufacturing, validation, design changes and quality systems.

You will influence how Quality Engineering operates as the site scales, lead improvement projects and mentor others, while ensuring compliance with 21 CFR Part 820, ISO 14971 and risk management throughout the manufacturing lifecycle.