Director Failure Investigation

Danaher•Lodi, CA

14h•Onsite

About The Position

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.

Requirements

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.
Strong technical, analytical, and problem-solving skills
Applied experience in Lean Manufacturing and Lean Concepts

Nice To Haves

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

Responsibilities

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.