Senior Director, Quality Operations - Clinical Diagnostics

Regulatory Jobs; Chaska (MN); On-site; USD 230,000 - 250,000; Full time

Benefits offered by this job

Bonus/incentive pay

Competitive benefits

Professional development

Job summary

Beckman Coulter Diagnostics, a Danaher company, is seeking a Senior Director of Quality Operations for CCIA North America to drive quality across manufacturing and development sites in Chaska, MN and Carlsbad. You will oversee the QMS, regulatory alignment, and a large quality organization, fostering a culture of continuous improvement and patient safety.

The role requires extensive leadership experience in IVD/medical devices, deep process knowledge, and collaboration across Operations, R&D,

Qualifications

• Bachelor’s or higher in science/engineering with 20+ years’ experience.
• 10+ years of quality leadership in IVD or medical devices.
• Experience leading multi-site quality orgs, regulatory inspections.
• Strong knowledge of FDA, ISO, and global regulatory frameworks.

Responsibilities

• Provide strategic and operational quality leadership for the Chaska site and other sites, driving a culture of quality.
• Oversee Quality Assurance, Quality Control, Process Validation, Design Quality, and supplier quality.
• Ensure ongoing QMS compliance and regulatory inspections readiness.
• Own site quality performance and KPIs, address gaps with structured problem solving.
• Build and mentor a high-performing, diverse quality organization across functions.

Skills

Quality leadership

Multi-site leadership

Regulatory compliance

Problem solving

People leadership

DBS/continuous improvement

Education

Bachelor’s degree in science or engineering

Master’s or Doctoral degree in science or engineering

Tools

Quality systems (QMS)

Job description

Beckman Coulter Diagnostics, a Danaher company, is seeking a Senior Director of Quality Operations for CCIA North America to drive quality across manufacturing and development sites in Chaska, MN and Carlsbad. You will oversee the QMS, regulatory alignment, and a large quality organization, fostering a culture of continuous improvement and patient safety.

The role requires extensive leadership experience in IVD/medical devices, deep process knowledge, and collaboration across Operations, R&D,