Senior Engineering Consultant – Quality (Medical Device)

About the role

We are seeking a Senior Engineering Consultant to provide manufacturing and quality engineering support for a medical‑device manufacturing client. The role works closely with cross‑functional teams to resolve technical and quality issues and drive continuous improvement.

Key responsibilities

• Manufacturing engineering: troubleshoot processes, optimise yields, reduce scrap and rework, improve cycle‑times, and support equipment/tooling.
• Quality engineering: investigate non‑conformances, perform root‑cause analysis, support CAPA, conduct risk assessments and quality trend analysis.
• Process validation: assist with process characterization, IQ/OQ/PQ activities, develop validation protocols and reports, and maintain validated state.
• Change control: assess and implement technical changes to processes, equipment, materials, specifications and documentation.
• Continuous improvement: apply Lean, Six Sigma, statistical analysis and problem‑solving methods to enhance performance and product quality.
• Regulatory compliance: ensure activities meet ISO 13485, FDA and other applicable medical‑device requirements.
• Documentation: prepare and maintain engineering and quality records such as reports, FMEAs, risk assessments, work instructions and investigation files.
• Cross‑functional collaboration with Manufacturing, QA, R&D, Regulatory Affairs, Supply Chain and Maintenance.

Required profile

• Bachelor’s degree in Engineering.
• Minimum 8 years of relevant experience in manufacturing and quality engineering for medical devices.
• Advanced proficiency with MS Office applications (Word, Excel, PowerPoint, Project, Visio).
• Strong knowledge of Lean, Six Sigma and statistical analysis tools.

Required skills

• MS Office (Word, Excel, PowerPoint, Project, Visio).
• Minitab statistical software.
• Lean and Six Sigma methodologies.
• Process validation (IQ, OQ, PQ).
• Root‑cause analysis and CAPA.
• Risk assessment and FMEA.
• ISO 13485 and FDA regulatory requirements.