Quality Operations Manager; Buffalo Grove

Title: Quality Operations Manager

Location: Lincolnshire, IL

Hire Type: Direct-hire, Onsite

Compensation: $120K - $140K/year

Benefits: PTO, Paid Holidays, Medical/Dental/Vision plans, 401(k)

Must have Skill Set: Managing other quality supervisors and quality staff in a regulated environment

The Quality Operations Manager is responsible for leading site-level quality operations within a regulated medical device manufacturing environment. This role oversees quality assurance and quality control activities, drives compliance with regulatory and customer requirements, and supports continuous improvement of quality systems and processes. The Quality Operations Manager provides direct leadership to quality supervisors and staff while partnering cross-functionally with manufacturing, engineering, and operations leadership to ensure product quality, operational efficiency, and customer satisfaction.

• Lead and manage day-to-day quality operations, including quality assurance and quality control processes across manufacturing operations.
• Provide direct leadership to quality supervisors and quality engineering staff, including coaching, development, and performance management.
• Ensure compliance with applicable regulatory requirements, quality system standards, and internal procedures.
• Drive continuous improvement of quality processes, metrics, and systems to improve product quality and operational performance.
• Lead and oversee Corrective and Preventive Action (CAPA) activities, customer complaints, nonconformance investigations, and root cause analysis.
• Guide quality engineers in responding to customer feedback, audit findings, and regulatory inquiries.
• Partner with manufacturing and engineering teams to support process validation, product quality improvements, and risk mitigation initiatives.
• Monitor and report quality performance metrics, ensuring follow-up actions align with site quality plans and objectives.
• Support internal and external audits and ensure timely closure of audit findings.
• Provide technical quality leadership by contributing to site and organizational quality improvement roadmaps.
• Promote a culture of quality, accountability, and continuous improvement across the organization.

• Bachelor’s degree preferred with 10+ years of related experience; equivalent combinations of education and experience will be considered.
• Experience working in a highly regulated manufacturing environment, such as medical device or pharmaceutical manufacturing, is required.
• Proven experience managing quality supervisors or quality managers and leading quality teams in a production environment.
• Strong working knowledge of quality systems, regulatory compliance, and audit readiness.
• Lean Six Sigma Black Belt certification (ASQ, BQF, or equivalent) is highly preferred.
• Project Management certification (PMI or recognized equivalent) is highly preferred.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.