Sr Quality Engineer

About the role

The Senior Quality Engineer will support quality assurance activities in a regulated medical-device manufacturing environment. You will ensure that products and processes meet all applicable quality, regulatory and business requirements while driving continuous improvement.

Key responsibilities

• Develop, modify and maintain quality standards and protocols for material processing and finished products.
• Collaborate with engineering, manufacturing, supplier quality and operations to embed quality requirements.
• Design and implement inspection and testing methods, including statistical analysis of results.
• Lead investigations, non-conformance management, CAPA, change control and validation deliverables.
• Perform risk assessments, process monitoring and ensure audit readiness for FDA, ISO and GMP audits.
• Document corrective actions and maintain compliance with internal quality systems.

Required profile

• Bachelor’s degree in engineering (or Master’s/PhD with reduced experience requirement).
• Minimum 4 years of relevant engineering, quality or manufacturing experience (or 2 years with a Master’s degree).
• Strong technical problem-solving ability and knowledge of regulated quality systems (FDA, ISO, GMP).
• Experience producing clear, audit-ready documentation.

Required skills

• Statistical analysis
• Validation
• CAPA management
• Change control
• Risk assessment
• Audit readiness
• FDA regulations
• ISO standards
• GMP compliance