Manager, Quality Assurance

The Manager, Quality Operations will oversee quality-related activities within the Quality Operations structure in a management capacity, including but not limited to the following:

• 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.

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum 6 years of experience in a medical device, pharmaceutical, biomedical, automotive, or other regulated manufacturing environment.
• Experience leading quality assurance or quality operations activities within a regulated industry.
• Experience supporting FDA inspections, notified body audits, and other regulatory audits.
• Knowledge of global quality regulations, standards, and quality management systems.
• Working knowledge of quality tools including Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, and Six Sigma methodologies.
• Experience managing nonconformances, CAPAs, quality investigations, and risk assessments.
• Experience implementing quality improvement initiatives and driving organizational change.

• 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.

• USN
  : $118,000 - $196,700 USD Annual

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