Senior Supplier Quality Engineer, New Product Dev (Onsite)

COV Covidien LP; North Haven (CT); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic seeks a Senior Quality Engineer in the Surgical Operating Unit to influence design for manufacturability, oversee supplier processes, and ensure robust manufacturing. You will manage supplier qualification, PPAP, and process validation while supporting medical device development and design controls in a regulated environment.

The role requires strong analytical skills, cross-functional collaboration, and leadership to drive quality improvements, supplier CAPA, and successful design

Qualifications

• Bachelor's degree in engineering or related technical field and 4+ years of relevant experience, or advanced degree with 2+ years.
• Extensive understanding of manufacturing processes for plastics, metals, electronics and/or product assembly.
• Strong knowledge of GD&T, FMEA and DFX principles within a regulated environment.
• Experience with supplier management, PPAP, process validation and regulatory compliance.
• Proven analytical, problem-solving and cross-functional collaboration skills.
• Leadership and project management capabilities with multi-project exposure.

Responsibilities

• Select and qualify suppliers to ensure quality parts, materials and services.
• Monitor parts through manufacturing, identify and resolve supplier-related issues.
• Evaluate supplier capabilities to meet product, process, quality and business needs.
• Manage NCMRs and supplier change requests with proper reporting.
• Maintain Approved Supplier List through audits and agreements.
• Qualify materials via PPAP including process validation and technical writing.
• Drive supplier performance improvements and reduce escapes through CAPA and reviews.
• Oversee IQ/OQ/PQ validation and Master Validation Planning in NPD.
• Perform statistical analysis of manufacturing process performance.
• Collaborate to capture process controls in design and manufacturability discussions.

Skills

GD&T

FMEA

DFX

Supplier management

Process validation

Statistics

Project management

Design for Manufacturability and ASB

Education

Bachelor's degree in engineering

Advanced degree

Tools

SAP

Trackwise

Windchill

Agile

Job description

Medtronic seeks a Senior Quality Engineer in the Surgical Operating Unit to influence design for manufacturability, oversee supplier processes, and ensure robust manufacturing. You will manage supplier qualification, PPAP, and process validation while supporting medical device development and design controls in a regulated environment.

The role requires strong analytical skills, cross-functional collaboration, and leadership to drive quality improvements, supplier CAPA, and successful design