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Job Title: Production Quality Lead
Shift: 2:00 PM - 10:30 PM
Location: Menlo Park, CA
26-02460 Position Summary
The Production Quality Lead is responsible for supervising quality engineers and technicians while supporting and maintaining the organization's Quality Management System. This role leads medium-sized technical projects, ensures regulatory compliance, and drives continuous improvement initiatives across production and quality operations. The position requires strong technical expertise, project leadership, and the ability to manage multiple concurrent initiatives within a regulated manufacturing environment. Key Responsibilities Quality Systems & Compliance
Ensure implementation and effectiveness of the Quality Management System in accordance with internal procedures and regulatory requirements (e.g., FDA, BSI, and other applicable standards)
Monitor daily work operations and provide direction to quality engineers, technicians, and staff to achieve operational and project goals
Maintain compliance through documentation, audits, and continuous monitoring of quality processes
Address quality system issues directly or delegate project work to maintain system capability and regulatory compliance
Project Leadership & Technical Oversight
Lead or independently manage medium-sized technical projects using conventional and risk-managed execution plans
Manage multiple concurrent projects involving complex technical analysis and cross-functional coordination
Lead complex investigations and technical problem-solving initiatives that may require new methods or approaches
Serve as a Subject Matter Expert (SME) or Independent Technical Expert (ITE) on specific technical areas within quality projects
Participate in and lead cross-functional teams to support organizational objectives
Team Leadership & Development
Supervise and support quality engineers and technicians
Assist in the development of direct reports through training, coaching, and progressively challenging assignments
Conduct formal performance evaluations and apply progressive disciplinary actions when appropriate
Provide technical guidance and mentorship to team members
Operational Support & Process Improvement
Identify, develop, and implement process improvements to enhance department performance and quality system effectiveness
Direct quality personnel in supporting quality system initiatives in coordination with management, project leaders, and design engineers
Evaluate project costs and support financial oversight within quality initiatives
Develop and contribute to operational policies and procedures affecting personnel and workflow within the organizational unit
Communication & Stakeholder Engagement
Interact regularly with internal and external stakeholders to address requests, explain procedures, and resolve issues
Provide updates and reporting related to project progress, quality performance, and compliance activities
Qualifications
Bachelor's degree required
Minimum of 5 years of quality experience in a manufacturing or regulated industry environment
Demonstrated initiative, critical thinking, and problem-solving skills
Strong technical knowledge of quality concepts, practices, and procedures
Experience managing complex issues involving multiple competing factors
Technical & Professional Skills
Experience supervising or leading engineers and technical staff
Knowledge of quality systems, regulatory compliance, and documentation standards
Familiarity with financial systems and fiscal controls related to project or departmental budgets
Ability to analyze complex data and technical problems to develop effective solutions
Strong communication, organizational, and leadership skills
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