Senior Supplier Quality Engineer (Medtech)

TL;DR

Senior Supplier Quality Engineer (Medtech): Executing supplier quality activities for the development and launch of innovative cardiac surgery devices with an accent on component qualification, PPAP, and regulatory compliance. Focus on managing supplier readiness, performing technical audits, and implementing corrective actions to ensure product reliability.

Location: Hybrid (Brooklyn Park, Minnesota, USA); must be onsite a minimum of 4 days per week

Salary: $99,200 - $148,800

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

• Lead supplier qualification activities, including process reviews, capability assessments, and readiness evaluations for NPD components.
• Manage and approve PPAP (Production Part Approval Process) activities to ensure alignment with quality standards.
• Conduct supplier audits to assess regulatory compliance and implement corrective and preventive actions.
• Collaborate with R&D, Manufacturing, and Sourcing teams to ensure components meet design intent and manufacturability.
• Resolve supplier-related quality issues using structured problem-solving methodologies.
• Define receiving inspection requirements and validate associated test methods.

Requirements

• Baccalaureate degree with 4+ years of experience, Master's with 2+ years, or a PhD.
• Unrestricted U.S. work authorization is required at the time of hire.
• Experience in supplier quality engagement throughout the New Product Development (NPD) lifecycle.
• Knowledge of industry standards and regulatory requirements for medical devices.

Nice to have

• Engineering experience in the medical device industry, specifically disposable devices or capital equipment.
• Familiarity with cardiovascular device applications and basic heart anatomy.
• Experience supporting cross-functional and cross-regional teams in a matrixed organization.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Employee Stock Purchase Plan (ESPP) and hirify.global Incentive Plan (MIP).
• Paid time off, paid holidays, and tuition reimbursement.
• Global well-being program (Simple Steps) and Employee Assistance Program.