Quality Manager - Manufacturing

Quality Manager – Manufacturing

Location: Hayward, CA | Onsite

Salary: $130,000–$155,000 annually, depending on experience

Employment Type: Full-Time

Our client is seeking an experienced Quality Manager to lead and strengthen quality systems within a specialized manufacturing environment in Hayward, CA.

This is a hands-on leadership role for someone who enjoys being involved with both the quality system and day-to-day manufacturing operations. The Quality Manager will work closely with Operations, Engineering, Manufacturing and senior leadership to ensure products and processes consistently meet customer, regulatory and quality requirements.

Key Responsibilities

• Lead and maintain the company's Quality Management System (QMS)
• Ensure compliance with applicable ISO 9001 and ISO 13485 requirements
• Support quality requirements within a highly controlled manufacturing and cleanroom environment
• Lead internal and external audits and ensure timely closure of findings
• Manage CAPA, nonconformances, root cause investigations and corrective actions
• Utilize problem-solving methodologies including 5-Why, Fishbone and 8D
• Oversee incoming, in-process and final inspection activities
• Monitor quality metrics and identify opportunities for continuous improvement
• Partner with Manufacturing and Engineering to resolve production and supplier quality issues
• Support document control, change control and quality record requirements
• Develop and improve quality procedures, work instructions and inspection processes
• Provide leadership, coaching and direction to Quality team members
• Promote a practical, collaborative approach to quality throughout the organization

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing or a related technical discipline preferred
• 7+ years of progressive Quality experience within a manufacturing environment
• Previous Quality leadership or management experience
• Strong working knowledge of ISO 9001; ISO 13485 experience highly preferred
• Experience with CAPA, RCA, audits, nonconformance management and continuous improvement
• Experience in semiconductor, medical device, high-purity manufacturing, precision manufacturing, specialty chemical or another highly regulated/controlled manufacturing environment is highly desirable
• Cleanroom experience is a strong plus
• Strong communication and leadership skills with the ability to work effectively with both production employees and senior management
• Comfortable being hands-on and visible on the manufacturing floor