Quality Manager – Medical Device Manufacturing

Quality Manager – Medical Device Manufacturing

Location: Libertyville, IL

Salary Range: $140,000 – $155,000/year + Bonus

Brief Overview:

Reporting to senior site leadership, the Quality Manager will lead the Quality function across both new product introduction (NPI) and sustaining manufacturing. This role will oversee a team of both quality engineers and quality technicians while driving compliance, continuous improvement, and remediation efforts within a regulated medical device environment.

A key priority for this role is leading and supporting RDA (Remediation) initiatives , ensuring quality systems, documentation, and processes meet regulatory requirements and industry standards.

What a typical day looks like:

• Provide leadership and direction to the site Quality team, including Quality Engineers and Inspectors
• Own and drive site-level Quality Management System (QMS) compliance (21 CFR 820, ISO 13485, ISO 14971)
• Lead and execute RDA / remediation activities, including gap assessments, documentation updates, and audit readiness
• Oversee product and process quality for both new product introduction and sustaining manufacturing
• Drive CAPA, nonconformance investigations, and customer complaint resolution to effective closure
• Ensure robust risk management practices (PFMEA, hazard analysis) are implemented and maintained
• Guide development and execution of inspection plans, control plans, and process validation activities
• Leverage statistical methods (SPC, DOE) to support data-driven decision making and process improvements
• Partner cross-functionally with Operations, Engineering, and Regulatory to resolve quality issues and improve processes
• Lead internal and external audits, including FDA and notified body inspections
• Drive continuous improvement initiatives using Lean and Six Sigma methodologies
• Establish and track key quality metrics, ensuring visibility and accountability across the organization
• Mentor and develop team members while fostering a culture of quality and compliance

The experience we’re looking to add to our team:

• Bachelor’s degree in Engineering or related technical field
• 8+ years of experience in Quality within a regulated manufacturing environment
• 3+ years of leadership or people management experience
• Strong background in medical device manufacturing (21 CFR 820, ISO 13485, ISO 14971 required)
• Direct experience leading or supporting RDA / remediation efforts (highly preferred / critical)
• Experience with molding manufacturing processes (preferred)
• Strong experience with CAPA, risk management, and audit support
• Working knowledge of statistical tools (SPC, DOE)
• ASQ Certification (CQE, CQM, or similar) preferred