Quality Assurance Specialist Lead

About the role

The Quality Assurance Specialist Lead position is located in Santa Clara, California. This role supports and maintains the effectiveness of the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, internal quality standards, and organizational objectives.

Responsibilities

• 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).
• 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 preventive action (CAPA) activities, ensuring appropriate documentation and resolution.
• Monitor compliance with established quality standards and participate in internal and external audits, inspections, and compliance assessments as required.
• Promote a culture of quality, compliance, continuous improvement, and customer focus throughout the organization.

Qualifications

• Education: Associate’s degree in Engineering, Life Sciences, Quality Management, Business, or a related discipline preferred.
• Skills & Capabilities: Experience in Quality Assurance, Quality Systems, Regulatory Compliance, Manufacturing Quality, or a related field. Knowledge of applicable quality system regulations and standards, including FDA regulations, ISO standards, Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), as appropriate. Strong analytical, problem-solving, and risk assessment skills. Excellent written and verbal communication skills with the ability to influence and collaborate across functional teams. Proficiency in quality management systems, quality metrics reporting, investigations, CAPA, and continuous improvement methodologies. Demonstrated ability to manage multiple priorities in a regulated environment while maintaining attention to detail and compliance.

Core Competencies

• Quality Systems Management
• ERP systems, LMS, QMS and Microsoft Office Suit
• Regulatory Compliance
• Risk Management
• Continuous Improvement
• Documentation Control
• Audit and Inspection Readiness
• Cross-Functional Collaboration
• Investigation and Root Cause Analysis
• Customer Focus
• Leadership and Accountability