Senior Supplier Quality Engineer - NPD

RiseMe; North Haven (CT); On-site; USD 110,000 - 140,000; Full time

Job summary

Medtronic is seeking a Senior Quality Engineer to join the Surgical Operating Unit, focusing on manufacturability, supplier collaboration, and robust process development. You will drive quality improvements through CAPA, PPAP, and validation activities, ensuring design transfer and regulatory compliance across production.

The role demands extensive technical knowledge of GD&T, FMEA, and ISO/FDA standards, with strong leadership and cross-functional influence in a fast-paced environment.

Qualifications

• Education: Degree in engineering or related technical field with 4+ years experience; or advanced degree with 2+ years.
• Extensive understanding of manufacturing processes, GD&T, FMEA, and DFX principles.
• Regulatory knowledge in regulated environments (FDA/ISO).
• Strong analytical, root-cause and cross-functional collaboration skills.
• Excellent written and verbal communication and leadership in projects.

Responsibilities

• Select and qualify suppliers ensuring quality parts and services.
• Monitor parts through manufacturing cycle and resolve supplier issues.
• Manage NCMRs and supplier change requests with reporting.
• Qualify materials via PPAP and perform process validation.
• Drive supplier performance improvements and CAPA management.
• Oversee IQ/OQ/PQ validation and Master Validation Planning.
• Collaborate to capture process controls in design and DFM/DFMEA.

Skills

Leadership

Communication

Problem solving

Regulatory knowledge

Education

Bachelor's degree in engineering

Advanced degree in a related field

Tools

SAP

Trackwise

Windchill

Agile

Job description

Medtronic is seeking a Senior Quality Engineer to join the Surgical Operating Unit, focusing on manufacturability, supplier collaboration, and robust process development. You will drive quality improvements through CAPA, PPAP, and validation activities, ensuring design transfer and regulatory compliance across production.

The role demands extensive technical knowledge of GD&T, FMEA, and ISO/FDA standards, with strong leadership and cross-functional influence in a fast-paced environment.