Senior Supplier Quality Engineer

🔥 0 minutes ago

🌽 Illinois, Minnesota – Remote

🌽 Illinois – Remote ❄️ Minnesota – Remote

💵 $99.2k - $148.8k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Medtronic

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1949

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

Healthcare • Manufacturing • Healthcare Insurance

Medtronic is a global leader in healthcare technology solutions, working to address the most complex and challenging medical conditions. With over 95,000 employees in more than 150 countries, the company is focused on accelerating access to healthcare technologies and advancing inclusion, diversity, and equity in healthcare. Medtronic collaborates closely with healthcare professionals to innovate and optimize treatments and therapies, thus inspiring hope and new possibilities for patients worldwide. The company's commitment to healthcare extends to its focus on impactful solutions and sustainable practices.

📋 Description

• Manage quality oversight of strategic Contract Manufacturers, Original Equipment Manufacturers, and designated suppliers • Lead supplier quality activities for product and process changes, including risk assessment, qualification, validation, and implementation support • Monitor supplier performance metrics, identify quality risks and trends, and drive corrective and preventive actions • Plan, conduct, and support supplier audits for GMP, quality standards, and regulatory compliance • Partner with R&D, Regulatory Affairs, Operations, and Quality teams to ensure supplied products and components meet finished device requirements • Investigate supplier-related nonconformances, complaints, and quality issues • Facilitate root cause analysis and sustainable corrective actions • Support New Product Development activities, including supplier qualification, product acceptance strategies, control plans, and supplier quality deliverables • Define and maintain receiving inspection requirements, supplier controls, and quality documentation • Provide technical quality guidance across supplier-related activities throughout the product lifecycle

🎯 Requirements

• Bachelor’s Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience • For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required • Unrestricted U.S. work authorization at the time of hire and for the duration of employment • Up to 15% travel required • Experience with supplier quality systems, supplier qualification, supplier audits, or supplier performance management • Experience supporting quality processes within a regulated industry environment • Experience interpreting and applying quality system requirements, technical documentation, specifications, and quality standards • Experience supporting contract manufacturers, original equipment manufacturers, or external manufacturing partners within the medical device industry • Experience with new product development, product transfers, process validation, design transfer, or supplier onboarding • Lead Auditor or certified quality-related credential such as ASQ certification • Knowledge of ISO 13485, 21 CFR Part 820, Good Manufacturing Practices, and global medical device regulatory requirements • Experience leading supplier corrective actions, continuous improvement initiatives, and cross-functional quality projects

🏖️ 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 • Capital Accumulation Plan for eligible Vice Presidents and above or subject to IRS earning minimums • Temporary employees eligible for paid sick time as required by applicable state law • Competitive benefits package • Short-term incentive through the Medtronic Incentive Plan (MIP)