Senior Supplier Quality Engineer — NPD & GMP Leader

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

Job summary

Medtronic plc in the United States seeks a Senior Supplier Quality Engineer to drive quality across the New Product Development lifecycle, partnering with external suppliers and internal teams to ensure robust supplier controls and regulatory compliance. You will qualify suppliers, support process validation, develop control plans, and lead CAPA investigations to resolve issues and prevent recurrence.

A strong background in GMP, FDA/regulatory awareness, and cross-functional collaboration is

Qualifications

• Bachelor's degree in engineering or related field required.
• 4+ years in supplier quality, quality engineering, or medical device quality.
• Experience qualifying suppliers, processes, materials, or components.
• Experience applying root cause analysis, CAPA, risk management, or statistical methods.
• Knowledge of supplier quality systems, auditing practices, and quality control methodologies.
• Experience in regulated industries and quality management systems.
• FDA/ISO 13485/GMP knowledge preferred.
• ASQ CQE/CSQP or equivalent certification advantageous.

Responsibilities

• Lead supplier quality activities supporting New Product Development from concept to commercialization.
• Qualify suppliers, processes, materials, and components per QMS and regulatory requirements.
• Support supplier process validation, product acceptance sampling, and control plan development.
• Partner with suppliers and cross-functional teams to establish supplier controls and risk mitigation.
• Develop and implement product acceptance sampling strategies, control plans, and SQP programs for new products.
• Define receiving inspection requirements and validate internal test methods.
• Investigate supplier-related quality issues, perform root cause analysis, and drive CAPA.
• Conduct supplier audits and assessments to ensure GMP and regulatory compliance.
• Monitor supplier performance metrics and drive continuous improvement.

Skills

Root cause analysis

CAPA

Risk management

Statistical analysis

Quality systems knowledge

Auditing

GMP knowledge

FDA/regulatory knowledge

Supplier quality

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Master's degree

PhD

Tools

ASQ CQE

CSQP

Job description

Medtronic plc in the United States seeks a Senior Supplier Quality Engineer to drive quality across the New Product Development lifecycle, partnering with external suppliers and internal teams to ensure robust supplier controls and regulatory compliance. You will qualify suppliers, support process validation, develop control plans, and lead CAPA investigations to resolve issues and prevent recurrence.

A strong background in GMP, FDA/regulatory awareness, and cross-functional collaboration is