Senior Supplier Quality Engineer: Drive Supplier Excellence

BioCT Innovation Commons; North Haven (CT); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic is seeking a Senior Quality Engineer to join the Surgical Operating Unit within the new product development quality team. The role focuses on manufacturability, inspection, assembly, supplier collaboration, and process validation to ensure robust production for medical device development and design transfer.

The ideal candidate has strong experience in manufacturing processes, GD&T, FMEA, and regulatory compliance, with a background in quality systems and supplier performance.

Qualifications

• Bachelor’s degree in engineering or a related technical field plus relevant experience in a regulated environment.
• Experience with quality systems, manufacturing processes and supplier management.
• Knowledge of FDA/ISO quality standards (13485, 14971) preferred.
• Strong problem solving, communication, and leadership skills.

Responsibilities

• Lead supplier qualification and ensure quality parts and services.
• Monitor parts through manufacturing cycle and address supplier-related issues.
• Evaluate supplier capabilities to meet product and process requirements.
• Manage Non-Conformance Materials Reports (NCMRs) and supplier change requests.
• Oversee PPAP, process validation, and design transfer activities.
• Collaborate across functions to capture design controls and manufacturability considerations.
• Travel to supplier sites in the US and internationally as needed.

Skills

Quality engineering

Manufacturing processes

GD&T

Analytical thinking

Cross-functional collaboration

Leadership

Education

Bachelor's degree in engineering

Tools

SAP

Trackwise

Windchill

Agile

Job description

Medtronic is seeking a Senior Quality Engineer to join the Surgical Operating Unit within the new product development quality team. The role focuses on manufacturability, inspection, assembly, supplier collaboration, and process validation to ensure robust production for medical device development and design transfer.

The ideal candidate has strong experience in manufacturing processes, GD&T, FMEA, and regulatory compliance, with a background in quality systems and supplier performance.