Senior Quality Systems Specialist (Medtech)

TL;DR

Senior Quality Systems Specialist (Medtech): Managing and optimizing Quality Management System (QMS) processes for customer-related activities with an accent on ISO 13485 and FDA compliance. Focus on serving as the primary customer interface, coordinating order management in SAP, and ensuring audit readiness for a high-impact medical technology business.

Location: Must be based in Tempe, Arizona, USA (Onsite 5 days a week)

Salary: $93,600 – $140,400 USD

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative engineering solutions.

What you will do

• Optimize QMS frameworks to ensure alignment with ISO 13485 and FDA requirements.
• Serve as the primary point of contact for external customers regarding orders, complaints, and RMAs.
• Manage sales orders and shipment transactions within SAP.
• Create and maintain QMS documentation, including procedures and work instructions.
• Lead audit readiness efforts and act as a subject matter expert during regulatory inspections.
• Collaborate with Engineering and Planning teams to execute customer-requested changes.

Requirements

• Must possess unrestricted U.S. work authorization at the time of hire.
• Baccalaureate degree required.
• Minimum of 4 years of relevant experience (or 2 years with an advanced degree).
• Must be able to work onsite 5 days a week in Tempe, Arizona.
• Strong analytical skills and ability to interpret quality metrics.
• Excellent communication skills for stakeholder collaboration.

Nice to have

• Experience with SAP sales order and shipment modules.
• Familiarity with ISO 13485 and FDA quality standards.
• Background in complaint handling and RMA processes.
• Experience interfacing with Planning, Engineering, and Finance departments.

Culture & Benefits

• Competitive salary and hirify.global Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer match.
• Paid time off and paid holidays.
• Tuition assistance and professional development programs.
• Employee Stock Purchase Plan and well-being programs.