Senior Supplier Quality Engineer (Medical Devices)

Location: Grand Rapids, Michigan, United States; onsite five days per week. Minimal travel is required.

Salary: $99,200–$148,800 USD per year, plus eligibility for a short-term incentive plan.

Company

hirify.global develops healthcare technologies, including cardiovascular products, with operations across more than 150 countries.

What you will do

• Manage supplier quality performance and compliance for purchased materials, components, and services.
• Lead investigations into supplier quality issues, nonconforming materials, CAPAs, Material Review Board activities, and inspection findings.
• Coordinate supplier onboarding, Approved Supplier List additions, and supplier setup in quality and business systems.
• Partner with engineering and cross-functional teams on product acceptance strategies, supplier control plans, and quality requirements.
• Define receiving inspection requirements, support internal test method validation, and assess supplier change notifications.
• Analyze supplier performance using statistical techniques and drive improvements through Lean, Six Sigma, Kaizen, and other quality methodologies.

Requirements

• Bachelor’s degree in engineering, science, or a technical field with 4+ years of engineering or quality experience; alternatively, an advanced degree with 2+ years of experience or a PhD with no relevant experience.
• Experience in engineering and/or quality functions, preferably involving supplier quality, regulated manufacturing, or medical devices.
• Knowledge of quality systems, supplier controls, process validation, auditing, failure investigations, and nonconforming product management.
• Working knowledge of Quality System Regulation (21 CFR Part 820), ISO 13485, statistical quality control, and Six Sigma principles.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for this Senior-level role.
• Degrees earned outside the United States must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• ASQ Certified Quality Auditor or ASQ Lead Auditor certification.
• Experience developing protocols or reports and applying structured problem-solving methods.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project.

Culture & Benefits

• Purpose-driven healthcare technology environment focused on improving patient outcomes.
• Health, dental, and vision insurance, plus Health Savings and Healthcare Flexible Spending Accounts.
• Paid time off, paid holidays, disability coverage, life insurance, and employee assistance programs.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and a global well-being program.