Senior Supplier Quality Engineer (Medtech)

TL;DR

Senior Supplier Quality Engineer (Medtech): Managing supplier transfers and providing Quality Assurance Engineering representation for medical device development with an accent on component qualification, process validation, and regulatory compliance. Focus on ensuring product reliability, safety, and effectiveness through rigorous supplier assessment and lifecycle management.

Location: Must be based in Mounds View, Minnesota, USA. Role requires minimum 4 days per week onsite.

Salary: $99,200 – $148,800 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Manage supplier transfers within the Global Supplier Quality Supplier Change Implementation Team.
• Define and execute component qualification strategies (PPAP) and product acceptance plans.
• Provide quality compliance guidance throughout the product lifecycle, including design transfer to manufacturing.
• Perform and consult on supplier validations and evaluate internal supplier functions.
• Approve Engineering Change Notices, test methods, and test equipment to ensure compliance with medical device standards.
• Coordinate quality indicators and statistics to support business decision-making.

Requirements

• Bachelor’s Degree in Engineering, Science, or technical field with 4+ years of experience in a regulated industry (or Advanced Degree with 2+ years, or PhD with 0 years).
• Must possess unrestricted U.S. work authorization at the time of hire.
• Working knowledge of FDA regulations and ISO standards for medical devices.
• Experience with component qualification, PPAP, and product validation processes.
• Ability to travel periodically to suppliers or facilities (up to 25%).

Nice to have

• ASQ certification (CQE, CQA, or CSQP).
• Six Sigma, DFSS, or Lean Green/Black Belt certification.
• Experience with Windchill and Agile PLM systems.
• Technical knowledge of metrology, GD&T, and statistical analysis tools like Minitab.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA/FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and short-term/long-term disability leave.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.