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C
Cepheid
Director Failure Investigation
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What they do
A Director of Quality Assurance oversees and directs the overall operations of quality assurance within a company to ensure continuous improvement and compliance.
$169,784 / year median in California
-1% projected decline
Job Description
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology? At Cepheid, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System, which makes everything possible. The Director, Failure Investigation is responsible for leading failure investigation strategy, execution, and continuous improvement in a high-volume, regulated manufacturing environment. This role provides technical and operational leadership to ensure timely, compliant root cause investigations, effective corrective actions, and improved product quality, process reliability, and operational performance. This position reports to the Vice President, Manufacturing Operations and is part of the Lodi Operations team located in Lodi, CA, and will be an on-site role. In this role, you will have the opportunity to: Lead the Failure Investigation function by setting strategy, priorities, and operating expectations to ensure timely, thorough, and compliant investigations for Finished Goods, Consumables, and Reagents. Provide technical and operational leadership for complex failure investigations, including containment, root cause analysis, impact assessment, corrective and preventive actions, and effectiveness verification. Partner with Manufacturing, Quality, Engineering, Planning, Supply Chain, and other cross-functional teams to resolve recurring issues, reduce variation, and improve product and process reliability. Ensure failure investigations and related documentation meet applicable FDA, ISO, GMP, OSHA, and company quality system requirements, while supporting audits, inspections, management reviews, and quality system initiatives. Drive continuous improvement initiatives that reduce repeat failures, increase yield, improve Right First Time, strengthen operational performance, and monitor key performance indicators, investigation aging, repeat failure trends, CAPA effectiveness, and escalation processes. Lead, coach, and develop a team of technical staff by setting clear expectations, building investigation capability, and fostering a culture of accountability, quality, and continuous improvement. Communicate investigation status, risks, escalations, and recommendations to site leadership and key stakeholders in a clear, concise, and action-oriented manner. The essential requirements of the job include: Bachelor's degree with 8 or more years of experience OR Master's/Doctoral degree with 6 or more years of experience AND 4+ years managing people Experienced in regulated industries (FDA, ISO) Strong leadership capabilities and ability to collaborate in a complex environment Ability to communicate with other global sites which could include late hours, early mornings and at times weekends. This is a 24-hour operation support environment. Strong technical, analytical, and problem-solving skills Applied experience in