Quality Manager

Position Summary

We are seeking an experienced Quality Manager to lead Quality operations within a regulated medical device manufacturing environment. This role will oversee the site Quality Management System (QMS), regulatory compliance, manufacturing quality, audits, CAPA, and continuous improvement while leading the Quality team.

Key Responsibilities

• Lead site Quality operations and develop the Quality team.
• Maintain and improve the QMS in compliance with ISO 13485 and FDA 21 CFR Part 820/QMSR.
• Oversee manufacturing and product quality, including incoming inspection, nonconforming product, and product release.
• Lead CAPA, nonconformance, complaint investigations, root-cause analysis, and corrective actions.
• Lead and support FDA inspections, ISO/notified body audits, customer audits, and internal audits.
• Oversee supplier quality, qualification, performance, and corrective actions.
• Monitor Quality KPIs, trends, and risks to drive continuous improvement.
• Partner with Manufacturing, Regulatory, Purchasing, and global Quality teams to ensure compliance and product quality.
• Promote a strong Quality culture throughout the organization.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field; equivalent experience may be considered.
• 5+ years of Quality experience in regulated manufacturing, preferably within medical devices.
• 1+ years of people leadership experience.
• Strong knowledge of ISO 13485 and FDA QMSR.
• Experience with CAPA, nonconformances, audits, root-cause analysis, and manufacturing quality.
• Strong leadership, communication, problem-solving, and risk-based decision-making skills.

Preferred

• Lead Auditor experience or certification.
• Lean, Kaizen, or Six Sigma experience.
• Supplier Quality experience.
• SAP, Excel, and data analysis experience.
• Experience within a global medical device organization.

We are an Equal Opportunity Employer.