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.

• Direct quality activities related to supplier product and process modifications, including risk assessment, qualification, validation, and support for implementation.

• Track supplier performance metrics, recognize quality risks and trends, and promote corrective and preventive measures.

• Organize, execute, and assist in supplier audits to ensure compliance with GMP, quality standards, and regulatory requirements.

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

• Examine supplier-related nonconformances, complaints, and quality challenges; lead root cause analysis and implement sustainable corrective actions.

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

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

⛳️ 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 the criteria of 8 C.F.R. § 214.2(h)(4)(iii)(A) is mandatory.

• Proficient in supplier quality systems, supplier qualification, supplier audits, or managing supplier performance.

• Experience in supporting quality processes within a regulated industry setting.

• Skilled in interpreting and applying quality system requirements, technical documentation, specifications, and quality standards.

• Experience collaborating with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), or external manufacturing partners in the medical device sector.

• Familiarity with New Product Development (NPD), product transfers, process validation, design transfer, or supplier onboarding processes.

• Knowledgeable about ISO 13485, 21 CFR Part 820, Good Manufacturing Practices (GMP), and global medical device regulatory standards.

• Proven experience in leading supplier corrective actions, continuous improvement projects, and cross-functional quality initiatives.

• Must have unrestricted U.S. work authorization at the time of hire and maintain it for the duration of employment.

• Travel up to 15% is necessary.

🏝️ Benefits

• Competitive salary and a flexible Benefits Package.

• 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 matching.

• Short-term disability.

• Paid time off.

• Paid holidays.

• Employee Stock Purchase Plan.

• Employee Assistance Program.

• Non-qualified Retirement Plan Supplement.

• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).