Senior Quality Engineer

About the role

Medtronic is seeking a Senior Quality Engineer to lead quality initiatives for machining and secondary operations such as anodizing and final packaging. You will partner with cross‑functional teams to ensure that manufacturing processes, equipment, components, and documentation meet regulatory and Medtronic Quality Management System requirements.

Key responsibilities

• Define, implement, and sustain quality controls for machining, anodizing, and final pack processes.
• Develop inspection, testing, validation, and process evaluation methods to guarantee compliance with established specifications.
• Apply statistical analysis and quality engineering tools to assess process capability, support qualification, and investigate non‑conforming products or materials.
• Maintain disciplined documentation, traceability, and audit readiness for GMP, FDA, and ISO requirements.
• Lead or support investigations, corrective actions, CAPA, and validation activities, ensuring they are risk‑based and inspection‑ready.
• Collaborate with Manufacturing, Engineering, Supply Chain, and Quality partners to enable successful product launches and continuous improvement.

Required profile

• Extensive experience in quality engineering within a regulated manufacturing environment.
• Strong knowledge of GMP, FDA, and ISO standards applicable to medical device production.
• Proven ability to work with cross‑functional teams and drive compliance and process robustness.
• Excellent analytical skills for data‑driven decision making.

Required skills

• Machining and anodizing process knowledge
• Statistical analysis and quality engineering tools
• Process capability evaluation
• CAPA and validation methodology
• Regulatory compliance (GMP, FDA, ISO)
• Risk assessment and documentation