Senior Supplier Quality Engineer (Medical Devices)

Location: Grand Rapids, Michigan, United States; onsite five days per week

Salary: $99,200–$148,800 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops medical technologies for cardiovascular care and other healthcare applications, serving patients across more than 150 countries.

What you will do

• Manage supplier quality performance and compliance for purchased materials, components, and services.
• Lead investigations of supplier quality issues, nonconforming materials, CAPAs, material review activities, and inspection findings.
• Coordinate supplier onboarding, Approved Supplier List additions, and supplier setup in quality and business systems.
• Develop product acceptance strategies, supplier control plans, quality requirements, and receiving inspection requirements with engineering and cross-functional teams.
• Evaluate supplier change notifications and their impact on manufacturing, inventory, acceptance activities, and product configurations.
• Apply statistical quality techniques and Lean, Six Sigma, and Kaizen methods to identify trends and drive corrective actions.

Requirements

• Bachelor’s degree in engineering, science, or a technical field plus 4+ years of engineering or quality experience; alternatively, an advanced degree plus 2+ years or a PhD with no required experience.
• Experience with quality investigations, nonconforming products, corrective actions, or supplier quality concerns.
• Knowledge of quality systems, regulated manufacturing, supplier quality processes, and data-driven problem solving.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.

Nice to have

• Medical device or other regulated manufacturing experience, including supplier controls, process validation, auditing, and failure investigations.
• Working knowledge of 21 CFR Part 820, ISO 13485, statistical quality control, and Six Sigma principles.
• ASQ Certified Quality Auditor or ASQ Lead Auditor certification.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project.

Culture & Benefits

• Regular employee benefits include health, dental, and vision insurance, HSA, FSA, life insurance, and disability coverage.
• Paid time off, paid holidays, 401(k) with employer contribution and match, incentive plans, and an Employee Stock Purchase Plan.
• Tuition assistance or reimbursement, dependent daycare spending account, employee assistance, and global well-being resources.
• The role involves minimal travel and regular collaboration with manufacturing, suppliers, engineering, and other cross-functional teams.