Quality Assurance Specialist Lead

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Quality

Quality Assurance

Business Enablement/Support

Santa Clara, California, United States of America

Johnson & Johnson is currently recruiting for Quality Assurance Specialist Lead! This position will be located in Santa Clara, California.

The Quality Assurance Specialist Lead is responsible for supporting and maintaining the effectiveness of the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, internal quality standards, and organizational objectives. This role applies quality assurance principles and risk-based decision-making to support product quality, compliance initiatives, continuous improvement activities, and cross-functional collaboration. The incumbent serves as a quality advocate by identifying risks, driving corrective actions, and promoting a culture of compliance and operational excellence.

This individual will lead a team of quality special responsible for in-process quality inspections and the quality activities related to final product release of capital systems and accessories for a medical robotic system.

• Apply comprehensive knowledge of Quality Assurance principles, quality systems, and regulatory requirements to support the achievement of organizational goals and quality objectives.
• Review, assess, and approve quality-related documentation, including batch records and electronic batch records, and in-process labeling associated with manufacturing, operational, and business processes to ensure compliance with applicable procedures, standards, and regulations.
• Review and assess non-conformance investigations using SAP and EtQ, final product batch information in MES, equipment status in Maximo (CMMS) and complete business related trainings (LMS).
• Assist in the representation of the Quality Assurance department by attending and participating in meetings, projects, investigations and process improvements.
• Assign work to Quality Assurance technicians, understanding shifting priorities on short notice, delivering updates, communication and acting as the primary Quality Assurance technician for the team, reporting directly to the supervisor and/or management.
• Maintain and support routine collection, analysis, and reporting of quality metrics and key performance indicators (KPIs) to monitor system effectiveness and identify opportunities for continuous improvement.
• Participate in and lead risk mitigation initiatives, process improvement activities, and quality enhancement projects to improve operational efficiency, product quality, and regulatory compliance.
• Collaborate with cross-functional stakeholders to identify, assess, and mitigate quality and compliance risks while ensuring timely and effective customer support.
• Develop, revise, and maintain quality policies, procedures, work instructions, and related documentation in response to changing regulatory requirements, internal investigations, audit findings, and organizational needs.
• Support formal quality escalation processes by identifying, documenting, communicating, and tracking risks related to product quality, quality systems performance, and regulatory compliance.
• Assist in the investigation of quality events, deviations, nonconformances, complaints, and corrective and…