Supplier Quality Engineer II

Responsibilities

• Lead supplier qualification activities and approve suppliers in accordance with company standards
• Develop, prioritize, and execute risk-based supplier audit plans to ensure compliance with GMP and regulatory requirements
• Monitor supplier performance and proactively resolve quality issues from sourcing through manufacturing
• Provide Supplier Quality Engineering support for New Product Development (NPD) projects
• Partner with Component Engineering to develop product acceptance sampling strategies and control plans
• Define receiving inspection requirements and support the validation of internal test methods
• Implement strategies to prevent defects and drive continuous improvement in supplier quality systems

Requirements

• Bachelor's degree in Engineering or a Technical field with at least 2 years of relevant experience
• OR an Advanced degree in Engineering or a Technical field with 0 years of experience
• Knowledge of FDA 21 CFR Part 820
• Knowledge of ISO 13485
• Knowledge of Good Manufacturing Practices (GMP)

Preferred Qualifications

• Experience in supplier qualification, audits, and performance management within a regulated industry
• Experience supporting New Product Development (NPD) activities, including Design Controls and risk management
• Proficiency in quality engineering tools such as CAPA, root cause analysis, FMEA, and statistical techniques
• ASQ certification (CQE, CSQP) or Lean Six Sigma Green/Black Belt certification

Benefits

• Competitive salary and Medtronic Incentive Plan (MIP)
• Comprehensive health, dental, and vision insurance
• 401(k) plan with employer contribution and match
• Paid time off and paid holidays
• Tuition assistance and reimbursement programs
• Employee Stock Purchase Plan

About the Company

Medtronic is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life. Our Cranial & Spinal Technologies (CST) unit develops integrated ecosystems of spinal implants, robotic guidance systems, and advanced imaging tools to improve patient outcomes worldwide.