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

Medtronic • Lafayette, CO

4d • $99,200 - $148,800 • Onsite

About The Position

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. In this role, you will provide supplier quality support for Regional Expansions, Design Changes, and Supplier Development initiatives, partnering cross-functionally to ensure successful product commercialization and sustained supplier performance. You will lead supplier qualification and development activities, execute risk-based quality strategies, assess supplier performance, and drive compliance with applicable quality and regulatory requirements while fostering continuous improvement across the supply base.

Requirements

• Bachelors 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

Nice To Haves

• 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.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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.
• Serve as the Supplier Quality Engineering lead for New Product Development (NPD) programs, supporting Regional Expansions, Design Changes, and Supplier Development initiatives to ensure successful product launches and robust supplier readiness.
• Partner closely with Component Engineering, R&D, Manufacturing, Sourcing, and Post-Market Supplier Quality teams to establish supplier quality strategies, ensure effective supplier selection and qualification, and drive compliance throughout the product development lifecycle.
• 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.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior