Quality Engineering Manager

Key Responsibilities

• Lead quality engineering activities supporting manufacturing processes, equipment, facilities, utilities, and validation.
• Manage global product transfer projects and support new production line implementation.
• Partner with Manufacturing, Engineering, Validation, Regulatory, and Quality teams to ensure compliant execution of projects.
• Drive validation and qualification activities while ensuring compliance with cGMP and Quality System requirements.
• Lead risk assessments, change controls, and compliance remediation efforts.
• Present project updates, quality metrics, risks, and recommendations to leadership and stakeholders.
• Provide leadership to quality engineering resources while balancing project priorities and budgets.

Qualifications

• Bachelor's or Master's degree (Engineering strongly preferred).
• Certified Project Manager (CPM/PMP) strongly preferred.
• Experience leading global product transfers within the medical device industry.
• Direct experience supporting manufacturing and engineering sites setting up new production lines.
• Excellent presentation, communication, and stakeholder management skills.
• 8+ years of experience in Quality, Manufacturing, Engineering, QA/QC, or related functions within medical device, pharmaceutical, biologics, or regulated manufacturing.
• Previous leadership or project management experience preferred.
• Strong understanding of cGMP, validation, qualification, quality systems, and risk management.