Senior Director Quality Operations

Beckman Coulter Diagnostics; Chaska (MN); On-site; USD 150,000 - 200,000; Full time

Job summary

Beckman Coulter Diagnostics is looking for a Senior Director, Quality Operations in Chaska, Minnesota. This role involves providing senior-level operational quality leadership across manufacturing and development sites, ensuring compliance with quality management systems.

The ideal candidate will have over 20 years of experience, with strong leadership in quality within the in-vitro diagnostics or medical device industry. They will establish a culture of quality through collaboration and mentorship.

Qualifications

• 20+ years of experience in relevant fields.
• 10+ years of quality leadership experience in the IVD or medical device industry.
• Experience leading quality organizations in complex environments.

Responsibilities

• Provide operational quality leadership across multiple sites.
• Ensure compliance with QMS and regulatory requirements.
• Mentor and develop quality teams to drive performance.

Skills

Quality Leadership

Regulatory Compliance

Problem Solving

Process Validation

Team Development

Education

Bachelor’s degree in a scientific or engineering discipline

Master’s/Doctoral degree

Job description

Senior Director, Quality Operations – Clinical Chemistry Immunoassay (CCIA) North America provides senior‑level operational quality leadership for the Chaska, Minnesota and San Diego, California manufacturing and development sites, with accountability for manufacturing quality and development quality. This role translates enterprise quality strategy into disciplined site execution, ensures regulatory compliance, and drives a strong culture of quality across CCIA through close partnership with Operations, R&D, Supply Chain, and Regulatory Affairs.

This position reports to the Vice President, US Quality Operations and is a key member of the North America Quality Operations leadership team and will be based out of Chaska, Minnesota.

In This Role

• Provide strategic and operational quality leadership for the Chaska site and Carlsbad sites, driving a strong culture of quality across the CCIA organization and establishing followership through influence and matrixed collaboration with cross‑functional partners.
• Lead and be accountable for a complex, multi‑disciplinary quality organization, including Quality Assurance, Quality Control, Process Validation, Design Quality, Incoming Inspection, and sustained deployment of the Danaher Business System (DBS) to drive standard work, problem solving, and continuous improvement.
• Ensure sustained compliance with the Quality Management System (QMS) and applicable regulatory requirements, partnering with global and local stakeholders to standardize, simplify, and continuously improve quality processes.
• Own site quality performance and key performance indicators, proactively identifying gaps and leading structured problem‑solving to resolution when performance is at risk.
• Build and sustain an effective quality organization by ensuring appropriate staffing levels, clear role design, capability depth, succession coverage, and overseeing budget allocations required to consistently meet site performance, compliance, and delivery commitments.
• Build, mentor, and develop strong, diverse teams and quality leaders, fostering engagement, accountability, and leadership behaviors that inspire followership and ownership at all levels of the organization.
• Collaborate across all organizational levels, functions, and management chains to align priorities, communicate risk, and drive timely decisions to solution that protect patient safety and ensure the delivery of safe, compliant, high‑quality diagnostic products.

Essential Requirements

• 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 (e.g., 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, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel – up to 35% domestically and internationally per business needs.

It would be a plus if you also possess

• Leading regulatory inspections, audits, or remediation activities in a regulated diagnostics or medical device environment.
• Applying DBS or similar continuous improvement systems to improve quality performance and simplify processes.
• Supporting new product introductions or product transfers, partnering with R&D and Operations to ensure compliant commercialization.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or [e-mail].

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