Senior Supplier Quality Engineer - NPD & GMP Leader

Medtronic plc; Villalba (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Medtronic plc is seeking a Senior Supplier Quality Engineer to lead quality activities across the New Product Development lifecycle, ensuring suppliers meet GMP, regulatory, and performance requirements. You will partner with external suppliers and internal teams to establish supplier controls, drive product quality, and support qualification and launches of new products.

The role requires extensive experience in supplier quality, quality engineering, and working within regulated environments,

Qualifications

• Bachelor's degree required with 4+ years in supplier quality, quality engineering, manufacturing quality, or medical device experience; or advanced degree with fewer years.
• Experience qualifying suppliers, processes, materials, or components.
• Experience applying quality tools such as root cause analysis, CAPA, risk management, or statistical analysis.
• Knowledge of supplier quality systems, auditing practices, and quality control methodologies.
• Experience in regulated industries and quality management systems.

Responsibilities

• Lead supplier quality activities for New Product Development from concept to launch.
• Qualify suppliers, processes, materials, and components per quality system and regulations.
• Support supplier process validation, sampling, and control plan development.
• Collaborate with suppliers and cross-functional teams to establish controls and quality plans.
• Develop sampling strategies and Supplier Owned Quality programs for new products.
• Define receiving inspection requirements and validate internal test methods.
• Investigate supplier-related quality issues and drive CAPA to resolution.
• Conduct supplier audits to ensure GMP and regulatory compliance.
• Monitor supplier performance metrics and drive continuous improvement.

Skills

Root cause analysis

CAPA

Risk management

Statistical analysis

Auditing practices

Quality control methodologies

Education

Bachelor's degree in engineering or science

Job description

Medtronic plc is seeking a Senior Supplier Quality Engineer to lead quality activities across the New Product Development lifecycle, ensuring suppliers meet GMP, regulatory, and performance requirements. You will partner with external suppliers and internal teams to establish supplier controls, drive product quality, and support qualification and launches of new products.

The role requires extensive experience in supplier quality, quality engineering, and working within regulated environments,