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.
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.
