Quality Manager – Medical Devices - Intellectt : Job Details

Role: Quality Manager – Medical Devices

Location: Holdrege NE 68949

Duration: DIRECT-HIRE / FTE ONLY

What You'll Do:

• Lead all quality engineering and incoming quality activities at the Holdrege, NE site
• Oversee process and product validation, PFMEA, and quality control strategies
• Manage and mentor a team of quality engineers
• Ensure compliance with FDA, ISO, and internal quality systems
• Drive root cause analysis, CAPA, and continuous improvement initiatives (Lean, Six Sigma)
• Support internal and external audits (FDA, ISO, etc.)
• Collaborate cross-functionally with manufacturing, supply chain, and global quality teams
• Approve changes to the device master record, validations, and qualifications

What We're Looking For:

• Bachelor's degree in Engineering, Quality, or related field (Master's preferred)
• 3+ years in medical device manufacturing & validation
• 1+ year of people management experience
• Strong in quality tools: PFMEA, MSA, Validation, Root Cause, CAPA, Statistical Analysis
• Deep knowledge of Quality Systems, sampling plans, and regulatory requirements
• Experience with audits, compliance, and vendor qualification
• Bonus: Six Sigma certification, Project Management skills, and Risk Management experience