Supplier Quality Engineer II (Software, CRM, Medtech)

TL;DR

Supplier Quality Engineer II (Software - CRM): Review and approve software elements and SOUP items from external suppliers, partner with sourcing teams for supplier selection, evaluation, and ongoing monitoring. Focus on qualifying suppliers, performing audits, evaluating quality impact, and ensuring compliance for cardiac rhythm management products.

Location: Onsite in Mounds View, MN (4 days per week on-site), less than 10% travel. Must have unrestricted U.S. work authorization at time of hire.

Salary: $84,000 - $126,000 USD

Company

Global healthcare technology leader developing devices and therapies for cardiac rhythm management and heart failure.

What you will do

• Participate in software supplier selection teams to evaluate and approve suppliers.
• Evaluate quality impact of supplied software and apply necessary controls.
• Partner with sourcing to add and maintain suppliers on Approved Supplier List.
• Monitor supplier performance from acquisition through manufacturing and resolve issues.
• Perform periodic audits to ensure GMP and quality standards.
• Provide pre-market quality support to NPD teams for software qualification and compliance.

Requirements

• Bachelor’s degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering or related + minimum 2 years experience, or advanced degree with 0 years.
• Experience in engineering and/or quality roles.

Nice to have

• Understanding of IEC 62304 and ISO 13485/9001.
• Lead Auditor experience.
• Experience with vendors/suppliers.
• Familiarity with SOUP components and validation.
• Risk Management experience.
• Knowledge of DFSS, DFLS, DRM or robust design practices.

Culture & Benefits

• Competitive salary and hirify.global Incentive Plan (MIP).
• Health, dental, vision insurance; HSA, FSA; life insurance; long-term disability.
• 401(k) with employer match; tuition reimbursement; paid time off and holidays.
• Employee Stock Purchase Plan; Employee Assistance Program.
• Focus on inclusive culture, professional growth, and cross-functional collaboration.