Senior Director Quality Operations
$230,000–$250,000 year
On-siteSan Diego, California, United States or Chaska, Minnesota, United States
Job Summary
Senior Director, Quality Operations – Clinical Chemistry Immunoassay (CCIA) North America leads a multi-site quality organization across Chaska, Minnesota and Carlsbad/Carlsbad-related sites, translating enterprise quality strategy into disciplined site execution, ensuring regulatory compliance, and fostering a strong culture of quality. Responsible for Quality Assurance, Quality Control, Process Validation, Design Quality, Incoming Inspection, and deployment of the Danaher Business System to drive standard work, problem solving, and continuous improvement. Oversees site quality performance, staffing, budget, and cross-functional collaboration with Operations, R&D, Regulatory Affairs, and Supply Chain to deliver safe, compliant, high‐quality diagnostic products. Ensures ongoing QMS compliance, identifies gaps, and leads structured problem solving to remediation; builds and sustains a diverse, engaged quality leadership team; drives risk communication and timely decisions to protect patient safety and product quality; travel up to 35% as needed. Key requirements include advanced degree with extensive leadership experience in regulated diagnostics or medical devices, multi-site manufacturing/execution, and strong QA/QC knowledge, with a track record of regulatory inspections and continuous improvement. Location presence at Chaska, MN and Carlsbad, CA with global collaboration. This role reports to the VP, US Quality Operations and is a core member of the North America Quality Operations leadership team.
Required Qualifications
- Bachelor’s degree in a scientific or engineering discipline with 20+ years of experience, or Master’s/Doctoral degree with 18+ years of experience, including 6+ years of people leadership experience
- Minimum of 10 years of quality leadership experience with in-vitro diagnostics or medical device industry, with direct accountability for manufacturing and/or development quality
- Demonstrated experience leading quality organizations at multi-site or complex manufacturing environments, including responsibility for compliance, inspections, and operational performance
- Deep working knowledge of quality assurance, quality control, process validation, design quality, and supplier/incoming quality within regulated industries
- Strong understanding of IVD regulatory requirements and quality standards (FDA, ISO, global regulatory frameworks)
- Proven ability to lead structured problem solving, apply data and risk-based decision making, and drive sustainable corrective actions
- Travel up to 35% domestically and internationally
- Experience leading regulatory inspections, audits, or remediation activities in regulated diagnostics or medical device environments (preferred)
- Experience applying continuous improvement systems to improve quality performance and simplify processes (preferred)
- Experience supporting new product introductions or product transfers with R&D and Operations (preferred)
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.