Director Failure Investigation

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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll 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 worlds 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:

• Bachelors degree with 8 or more years of experience OR Masters/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 1020% primarily for planned training meetings or cross-site collaboration. Travel is expected to be primarily to Cepheids 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 its a health care program or paid time off our programs contribute to life beyond the job.

Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $160000 - $220000. 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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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