Manager, Supplier Quality Engineering (Medtech)

TL;DR

Manager, Supplier Quality Engineering (Medtech): Leading the supplier quality engineering team to ensure compliance and performance excellence for critical medical device components with an accent on FDA/ISO regulatory standards and supplier process improvement. Focus on managing root cause investigations, supplier audits, and cross-functional collaboration with procurement and manufacturing to maintain high-quality standards.

Location: Must be based in Deerfield, WI

Salary: $120,000–$145,000

Company

hirify.global is a global leader in medical devices and software solutions dedicated to improving patient outcomes for cardiopulmonary and respiratory conditions.

What you will do

• Manage and mentor a team of Supplier Quality Engineers to ensure timely performance and effective root cause analysis.
• Oversee supplier performance data, drive quality improvements, and conduct supplier audits as required.
• Collaborate with procurement, quality assurance, and manufacturing to resolve supplier certification and quality issues.
• Execute SQE strategy and ensure compliance with FDA and internal quality requirements.
• Support new product introduction, cost reduction, and part resourcing activities through resource management.
• Report supplier quality status and performance metrics to management.

Requirements

• Bachelor's degree in engineering or technical discipline or 10+ years of relevant experience.
• Minimum 7 years of experience in Supplier Quality Engineering with a strong background in auditing.
• Minimum 5 years of managerial experience in a technical environment.
• Working knowledge of manufacturing processes such as PCB assembly, injection molding, and machining.
• Proficiency in MS Office suite and MRP systems.
• Strong validation background in medical, automotive, or military fields.

Nice to have

• MBA degree.
• CMQ/OE, CQA, or CQE ASQ certifications.
• Familiarity with FDA QSR documentation requirements.
• Experience with ISO 9001/13485, Lean Manufacturing, and Six Sigma.

Culture & Benefits

• Comprehensive benefits plans including health and wellness programs.
• Annual bonus eligibility based on company performance.
• Opportunity to work on life-saving medical technology in a fast-growing global environment.
• Commitment to professional development and career growth.