Senior Supplier Quality Engineer - CST - Lafayette, CO (Onsite)

About the role

As a Senior Supplier Quality Engineer, you will play a key role in ensuring the quality, reliability, and long-term stability of supplier-provided materials, components, and services that support new product launches.

Responsibilities

• Lead supplier quality initiatives to ensure suppliers consistently deliver high-quality materials, components, and services that meet Medtronic's quality, regulatory, and business requirements.
• Drive supplier qualification, selection, and approval activities, supporting supplier certification programs and strategic supplier development initiatives that enhance quality, reliability, and cost-effectiveness.
• Monitor and evaluate supplier performance across the product lifecycle, proactively identifying, communicating, and resolving supplier quality issues while driving sustainable corrective and preventive actions.
• Develop, prioritize, and execute risk-based supplier audit plans to ensure compliance with Good Manufacturing Practices (GMP), quality management systems, and global regulatory requirements.
• Assess supplier quality systems, manufacturing processes, technical capabilities, and operational performance, providing leadership and guidance to drive continuous improvement and long-term supplier stability.
• Lead quality planning activities for purchased materials and components, ensuring compliance with applicable industry standards, regulatory requirements, and customer expectations while supporting design transfer and commercialization.
• Collaborate with Component Engineers to develop product acceptance sampling strategies, manage Approved Supplier List (ASL) activities, implement Supplier-Owned Quality (SOQ) programs, and establish effective control plans for new products.
• Define Receiving Inspection requirements, support validation of internal test methods, and ensure robust verification processes for supplier-provided components and materials.
• Drive defect prevention, risk mitigation, supplier capability improvement, and process optimization initiatives that strengthen supplier performance and ensure the delivery of safe, reliable, and high-quality medical devices.

Requirements

• Bachelor's degree in Engineering or Technical field with minimum of 4 years of relevant experience, OR
• Advance degree in Engineering or Technical field with minimum of 2 years of relevant experience.

Qualifications

• Experience supporting supplier qualification, supplier audits, supplier development, and supplier performance management within a regulated industry.
• Knowledge of quality management systems and applicable regulatory requirements, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Manufacturing Practices (GMP).
• Experience supporting New Product Development (NPD) activities, including Design Controls, risk management, process validation, and control plan development.
• Proficiency in quality engineering tools and methodologies, including CAPA, root cause analysis, statistical techniques, FMEA, and continuous improvement practices.
• Experience conducting supplier assessments and audits, with the ability to evaluate supplier quality systems and drive corrective actions.
• ASQ certification (CQE, CSQP) and/or Lean Six Sigma Green Belt or Black Belt certification preferred.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a team environment.
• Proficiency in Microsoft Office Suite.

Benefits

At Medtronic, we offer a competitive salary and a comprehensive benefits package, including:

• Health, Dental, and Vision Insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life Insurance
• Long-term Disability Leave
• Dependent Child Care Spending Account
• Tuition Assistance/Reimbursement
• Simple Steps (global well-being program)

Pay

$99,200.00 - $148,800.00 USD

Schedule

Onsite: At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This role will require