Senior Supplier Quality Engineer

Aurora Lifesciences; Yorkshire (VA); On-site; USD 85,000 - 110,000; Full time

Job summary

Aurora Lifesciences is seeking a Senior Supplier Quality Engineer to ensure compliance with medical device regulations and quality standards in the supply chain. This critical role involves oversight of logistics, warehousing, and distribution activities, ensuring conformance to ISO 13485, EU MDR, and FDA guidelines.

The successful candidate will have a bachelor's degree in a relevant field and a minimum of 5 years’ experience in quality assurance for regulated industries. Strong analytical skills and a compliance mindset are essential.

Qualifications

• Minimum 5 years’ quality experience in medical devices, pharmaceuticals, life sciences, or a regulated industry.
• Strong knowledge of ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820, and GDP.

Responsibilities

• Ensure compliance with ISO 13485, GDP, EU MDR, and FDA regulations.
• Provide quality oversight for product storage and distribution.
• Act as quality SME during audits.

Skills

Analytical skills

Problem-solving skills

Documentation and technical writing skills

Compliance mindset

Risk-based thinking

Stakeholder management

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Science, or a relevant technical discipline

Tools

Lean principles

Six Sigma tools

ERP systems

QMS platforms

Job description

Role Summary

The Senior Supplier Quality Engineer will ensure that logistics, warehousing, storage, handling, and distribution activities comply with medical device regulations and quality standards, including ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820, and GDP.

The role will provide quality oversight across the supply chain, from finished goods release through to customer delivery, supporting qualification audits, distribution controls, traceability, CAPA, risk management, validation, and continuous improvement.

Key Responsibilities

• The Supplier Quality Engineer will ensure logistics, warehousing, storage, handling, and distribution processes comply with ISO 13485, GDP, EU MDR, FDA 21 CFR Part 820, and internal QMS requirements.
• Support and improve QMS processes relating to warehousing, logistics, distribution, and product quality.
• Act as quality SME for logistics and distribution processes during internal and external audits.
• Provide quality oversight for product storage, packaging, labelling, shipment, environmental controls, and sterile medical device handling.
• Review and approve shipping, transport validation, and related distribution documentation.
• Maintain product traceability, including batch, lot, and serialisation controls where applicable.
• Monitor logistics providers, warehouses, distributors, and external quality performance.
• Plan, lead, and conduct qualification, surveillance, and remote audits.
• Evaluate external partners against regulatory, internal, contractual, and customer requirements.
• Prepare audit plans, checklists, reports, findings, non conformances, observations, and follow-up actions.
• Ensure quality agreements are established, maintained, and compliant.
• Investigate non conformances, investigations, deviations, complaints, and logistics-related quality issues.
• Lead or support CAPA activities, including containment, root cause analysis, corrective actions, preventive actions, and effectiveness checks.
• Support risk management activities, including ISO 14971, PFMEA review, change impact assessment, and non-conformance risk review.
• Provide quality engineering support for process validation, equipment qualification, and transport validation activities.
• Review and approve quality records, procedures, technical reports, and supporting documentation.
• Analyse quality KPIs and drive continuous improvement across logistics and distribution processes.

Required Education and Experience

• The Supplier Quality Engineer will hold a bachelor’s degree in Engineering, Science, or a relevant technical discipline.
• Minimum 5 years’ quality experience in medical devices, pharmaceuticals, life sciences, or another regulated industry.
• Strong knowledge of ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820, GDP, and medical device distribution requirements.
• Experience with qualification audits, monitoring, quality agreements, non conformances, investigations, root cause analysis, CAPA, and risk management.
• Familiarity with validation principles, including process validation, equipment qualification, and transport validation.
• Working knowledge of Lean principles, Six Sigma tools, ERP systems, and QMS platforms.
• ISO 13485 Lead Auditor certification required.
• FDA QSR / 21 CFR Part 820 audit training required.
• EU MDR training or qualification preferred.

Skills and Competencies

• The Supplier Quality Engineer will have strong analytical, problem-solving, and root cause analysis skills.
• High attention to detail and a strong compliance mindset.
• Excellent documentation and technical writing skills.
• Ability to apply risk-based thinking and process improvement methods.
• Strong communication, stakeholder management, and cross-functional collaboration skills.
• Ability to prioritise work, manage multiple tasks, and work independently in a regulated environment.
• Hands-on approach with the ability to support logistics partners and internal teams.