Supplier Quality Engineer II (Medical Devices)

Location: Brooklyn Center, Minnesota, United States; onsite four days per week. Limited travel of up to 15% may be required for supplier engagements, audits, and business needs.

Salary: $80,000–$120,000 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies and medical devices that support patient care worldwide.

What you will do

• Lead investigations and resolution of supplier-related quality and compliance issues found during incoming inspection or manufacturing.
• Drive supplier CAPA activities, including root-cause analysis, containment, effectiveness verification, and closure.
• Define and execute component qualification strategies, including PPAP, qualification planning, and release-readiness assessments.
• Evaluate supplier change requests and maintain supplier quality controls, acceptance strategies, control plans, and approved supplier documentation.
• Collaborate with engineering, manufacturing, operations, and suppliers to resolve technical and product-quality concerns.
• Assess supplier performance through quality metrics, audits, and operational reviews, and support internal and external regulatory audits.

Requirements

• Bachelor’s degree in engineering, science, or a technical field with 2+ years of engineering or quality experience, or an advanced degree with no prior experience required.
• Experience with quality systems, supplier quality, manufacturing quality, product quality, or engineering in a regulated or technical industry.
• Experience investigating nonconformances and implementing corrective actions using structured problem-solving methods.
• Knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820 requirements.
• Must possess unrestricted U.S. work authorization at the time of hire and throughout employment; sponsorship is not available for roles below Principal level.
• Baccalaureate degrees earned outside the United States must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Experience with Lean Six Sigma or DMAIC methodologies; Green Belt or Black Belt certification is preferred.
• Experience with statistical process control, risk management, CAPA, supplier quality systems, or supplier change management.
• Medical device experience, including component qualification, validation, or automated optical inspection validation.

Culture & Benefits

• Purpose-driven work developing healthcare technologies that improve patient outcomes.
• Health, dental, and vision insurance, plus health and flexible spending accounts for eligible regular employees.
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and disability coverage.
• Tuition assistance or reimbursement, life insurance, employee assistance resources, and employee stock purchase plan.