QA Manager

As Quality Manager I, you will oversee 5-8 direct reports and lead the Quality Assurance function for instrument and regulated consumable manufacturing, service, and support operations. You will implement and maintain quality system processes, ensure regulatory compliance (ISO 13485 and FDA GMP), and provide quality oversight. Strong leadership, communication, critical thinking, and organizational skills are required. You will manage a high‑performing, flexible team in a matrix environment, translating the company's quality strategy into SOPs and procedures to meet global standards across Nor Cal sites.

The role includes developing and executing both short‑term and long‑term strategies to improve and streamline quality processes.

• Ensure Compliance & Readiness
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  Direct activities across all Northern California sites to maintain continuous compliance and inspection readiness. Analyze and present data to senior management to confirm resource adequacy and prioritize projects in alignment with regulatory requirements and business goals.
• Monitor Quality Health
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  Use data‑driven insights to evaluate the effectiveness of Quality Operations processes and systems, identifying opportunities for improvement.
• Advise on Product Performance
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  Guide site teams on appropriate actions to address product performance issues and maintain quality standards.
• Approve Changes
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  Evaluate and authorize product and process changes to ensure conformity with specifications and regulatory requirements.
• Drive Quality Compliance
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  Oversee QA operations to uphold GMP, ISO, and regulatory standards, safeguarding product quality and patient safety.
• Support Manufacturing Excellence
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  Collaborate with production teams to resolve quality issues, implement corrective actions, and drive continuous improvement.
• Manage Documentation
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  Ensure timely review and approval of batch records, SOPs, and quality documentation for accuracy and compliance.
• Foster a Quality Culture
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  Provide training and guidance to cross‑functional teams, promoting proactive quality practices.
• Lead Collaboration
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  Serve as the QA liaison for Northern California operations, aligning with corporate standards and supporting audits and inspections.
• Supervise and manage daily operations, including team workload distribution, employee development, and training.
• Develop and improve Quality Management System (QMS) procedures and training materials.
• Support audits, inspections, and other quality and compliance activities.
• Make timely, effective decisions in a fast‑paced, sometimes stressful environment, while promoting a quality‑driven culture throughout the organization.

• Education:
  
  Bachelor's degree in Life Sciences, Engineering, or a related field required.
• Work Experience:
  
  Minimum 5 years of experience in quality systems, including supervisory responsibilities.
• Experience as a GMP (Good Manufacturing Practice) and/or ISO trainer is highly desirable.
• Experience working in a global organization or with multiple manufacturing sites is a plus.
• Certifications such as Quality Engineer, Quality Manager, Six Sigma Green Belt or Black Belt are preferred.
• Strong knowledge of ISO 13485, GMP, and other regulatory requirements.
• Proven experience in audit planning and execution.
• Excellent communication and leadership skills.

At Bio‑Rad, we're empowered by our purpose and recognize that our employees are too. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio‑Rad's robust offerings serve to enrich the overall health, wealth, and well‑being of our employees and their families through the various stages of an employee's work and life cycle.

We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401(k) plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities,…