Director Failure Investigation

Danaher Corporation; Lodi (CA); On-site; USD 160,000 - 220,000; Full time

Job summary

Cepheid, a Danaher operating company, seeks a Director of Failure Investigation to lead strategy and execution in a high-volume, regulated manufacturing environment at the Lodi, CA site. You will drive containment, root-cause analysis, CAPA effectiveness, and cross-functional coordination to improve product quality and process reliability.

The role requires a strong technical background, 8+ years in regulated settings, and proven leadership with the ability to communicate across global sites,

Qualifications

• Experience leading failure investigation strategy in regulated manufacturing environments.
• Strong leadership and collaboration across cross-functional teams.

Responsibilities

• Lead failure investigation function by setting strategy, priorities, and operating expectations for finished goods, consumables, and reagents.
• Provide technical and operational leadership for complex investigations including containment, root-cause analysis, impact assessment, CAPA, and verification.
• Partner with Manufacturing, Quality, Engineering, Planning, and Supply Chain to reduce variation and improve reliability.
• Ensure investigations meet FDA, ISO, GMP, OSHA and quality system requirements and support audits and management reviews.
• Drive continuous improvement to reduce repeat failures, increase yield, and strengthen operational performance.
• Lead, coach, and develop a team of technical staff with clear expectations and accountability.

Skills

Leadership

Regulated industries experience

Communication

Analytical problem-solving

Lean Manufacturing

Education

Bachelor’s degree

Master’s/Doctoral degree

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 (https://danaher.com/our-businesses) 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, (https://www.danaher.com/how-we-work/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 Lean Manufacturing and Lean Concepts

Travel Requirements:

• Occasional travel, approximately 10–20%, primarily for planned training, meetings, or cross-site collaboration. Travel is expected to be primarily to Cepheid’s headquarters in Sunnyvale, CA.

It would be a plus if you also possess previous experience in:

• Knowledge of Good Manufacturing Practices (GMP)
• Experience in a high-volume manufacturing environment
• Life science experience

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

The annual salary range for this role is $160,000 – $220,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].