Director of Failure Investigation & Quality Improvement

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

Benefits offered by this job

Bonus/incentive pay

Job summary

Cepheid, a Danaher operating company, is seeking a Director of Failure Investigation to lead strategy, execution, and continuous improvement in a high-volume regulatory manufacturing environment on-site in Lodi, CA.

You will guide root-cause analyses, CAPAs, and cross-functional collaboration across Manufacturing, Quality, Engineering, Planning, and Supply Chain to drive quality, yield, and Right First Time, with opportunities for coaching and leadership development.

Qualifications

• Bachelor’s degree with 8+ years of experience or Master’s/Doctoral with 6+ years and 4+ years managing people.
• Experience in regulated industries (FDA, ISO) with strong leadership.
• Willingness to support a 24-hour operation including late hours, early mornings, and weekends.
• Strong technical, analytical, and problem-solving skills.
• Applied experience in Lean Manufacturing and Lean Concepts.

Responsibilities

• Lead the Failure Investigation function by setting strategy, priorities, and operating expectations for investigations across Finished Goods, Consumables, and Reagents.
• Provide technical and operational leadership for complex investigations including containment, root-cause analysis, impact assessment, CAPAs, and effectiveness verification.
• Partner with Manufacturing, Quality, Engineering, Planning, Supply Chain, and cross-functional teams to resolve recurring issues and improve reliability.
• Ensure investigations and documentation meet FDA/ISO/GMP/OSHA and quality system requirements for audits and improvements.
• Drive continuous improvement initiatives to reduce repeats, improve yield and Right First Time, and monitor KPIs and aging.
• Lead, coach, and develop a team of staff with clear expectations and accountability for quality and improvement.
• Communicate status, risks, escalations, and recommendations to site leadership and stakeholders clearly.

Skills

Leadership

Regulated industry experience

Problem-solving

Lean Manufacturing

Communication

Cross-functional collaboration

Education

Bachelor’s degree or higher

Job description

Cepheid, a Danaher operating company, is seeking a Director of Failure Investigation to lead strategy, execution, and continuous improvement in a high-volume regulatory manufacturing environment on-site in Lodi, CA.

You will guide root-cause analyses, CAPAs, and cross-functional collaboration across Manufacturing, Quality, Engineering, Planning, and Supply Chain to drive quality, yield, and Right First Time, with opportunities for coaching and leadership development.