Senior Supplier Quality Engineer

This is a fully remote position, open to applicants in Illinois, +1 more state.

📋 Description

• Oversee quality management of strategic Contract Manufacturers, Original Equipment Manufacturers, and selected suppliers.

• Spearhead supplier quality initiatives related to product and process modifications, encompassing risk evaluation, qualification, validation, and implementation assistance.

• Track supplier performance metrics, identify quality risks and trends, and initiate corrective and preventive measures.

• Organize, conduct, and assist in supplier audits for GMP, quality standards, and regulatory compliance.

• Collaborate with R&D, Regulatory Affairs, Operations, and Quality teams to ensure that supplied products and components align with finished device specifications.

• Examine supplier-related nonconformities, complaints, and quality issues.

• Facilitate root cause analysis and implement sustainable corrective actions.

• Assist in New Product Development efforts, including supplier qualification, product acceptance strategies, control plans, and supplier quality deliverables.

• Establish and uphold receiving inspection criteria, supplier controls, and quality documentation.

• Offer technical quality guidance throughout supplier-related activities across the product lifecycle.

⛳️ Requirements

• Bachelor’s Degree in Engineering, Science, or a technical field with 4 years of experience in Engineering and/or Quality, OR an Advanced degree in Engineering, Science, or a technical field with 2 years of experience in Engineering and/or Quality, OR a PhD with no relevant experience.

• For degrees obtained outside the United States, a degree that meets 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

• Must possess unrestricted U.S. work authorization at the time of hire and maintain it throughout employment.

• Willingness to travel up to 15% as needed.

• Proven experience with supplier quality systems, supplier qualification, supplier audits, or supplier performance management.

• Familiarity with quality processes in a regulated industry environment.

• Competence in 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 sector.

• Background in new product development, product transfers, process validation, design transfer, or supplier onboarding.

• Certification as a Lead Auditor or a recognized 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 projects, and cross-functional quality initiatives.

🏝️ 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 with 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 are eligible for paid sick time as required by applicable state law.

• Competitive benefits package.

• Short-term incentive through the Medtronic Incentive Plan (MIP).