Manager, Quality Engineering

What You Will Do

• Lead the Quality Assurance team, providing technical guidance and quality oversight across manufacturing and operations, supports functions to drive continuous improvement and compliance.
• Partner with site leadership to ensure products consistently meet customer expectations, regulatory requirements, and applicable quality standards.
• Develop, coach, and retain a high-performing team while fostering a culture of inclusion, accountability, collaboration, and employee engagement.
• Drive quality system compliance by partnering with functional leaders to establish, communicate, and maintain quality standards, requirements, and responsibilities.
• Lead site readiness activities and support internal, corporate, notified body, FDA, and other regulatory audits and inspections.
• Oversee the management of nonconforming products, product and process deviations, risk assessments, corrective actions, and preventive actions to ensure effective resolution and compliance.
• Monitor and improve Quality performance indicators, including NCR, CAPA, compliance, and operational quality metrics, and implement corrective actions for adverse trends.
• Support the development and execution of local and global Quality Operations strategies that improve product quality, operational efficiency, risk management, and regulatory compliance.

What You Need

• Bachelor’s degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical discipline.
• Minimum 6 years of experience in a technical, manufacturing, quality, or engineering role within a regulated industry.
• Minimum 3 years of experience leading teams, projects, or quality management activities.
• Experience working within a regulated manufacturing environment, including compliance with FDA and/or international quality standards.
• Experience supporting quality systems, audits, investigations, corrective actions, and process improvement initiatives.

Preferred Qualifications

• Master's degree in Business Management, Engineering, Science, or an MBA.
• Experience leading and developing high-performing quality teams in a manufacturing environment.
• Experience establishing quality strategies and performance improvement programs across multiple sites or business units.
• Black Belt, Green Belt, or equivalent Lean/Six Sigma certification.
• Experience supporting global quality systems, regulatory compliance initiatives, and continuous improvement programs.
• Experience influencing cross-functional stakeholders and driving quality culture initiatives.