Senior Supplier Quality Engineer — NPD Quality Leader

Medtronic plc; Puerto Rico; Sur place; USD 95 000 - 130 000; Plein temps

Résumé du poste

Medtronic plc is seeking a Senior Supplier Quality Engineer to provide quality engineering leadership across the full product lifecycle. You will ensure suppliers meet quality, regulatory, and performance requirements while collaborating with external suppliers and internal teams.

You will qualify suppliers, support process validation, define control plans, lead supplier audits, and drive CAPA to resolve issues.

Qualifications

• Bachelor's degree in a relevant field with 4+ years in supplier quality or related areas.
• Master's degree or PhD can substitute for experience as per listed requirements.
• Experience with quality tools (root cause analysis, CAPA, risk management, statistics) and supplier auditing.

Responsabilités

• Lead supplier quality activities supporting New Product Development from concept through commercialization.
• Qualify suppliers, processes, materials, and components per quality system and regulatory requirements.
• Support supplier process validation, product acceptance sampling, and control plan development.
• Partner with suppliers and cross-functional teams to establish robust supplier controls and risk mitigation.
• Develop and implement product acceptance sampling strategies, control plans, and Supplier Owned Quality programs for new products.
• Define receiving inspection requirements and validate internal test methods for supplier quality verification.
• Investigate supplier-related quality issues, identify root causes, and drive CAPA to resolution.
• Conduct supplier audits and assessments to ensure GMP, quality standards, and applicable regulations.
• Monitor supplier performance metrics and drive continuous improvement initiatives.

Connaissances

Root cause analysis

CAPA

Risk management

Statistical analysis

Auditing practices

Quality control methodologies

Formation

Bachelor's degree in a relevant field

Master's degree

PhD

Outils

GMP knowledge

ISO 13485

Quality management systems

Description du poste

Medtronic plc is seeking a Senior Supplier Quality Engineer to provide quality engineering leadership across the full product lifecycle. You will ensure suppliers meet quality, regulatory, and performance requirements while collaborating with external suppliers and internal teams.

You will qualify suppliers, support process validation, define control plans, lead supplier audits, and drive CAPA to resolve issues.