Senior Director Quality Assurance Filtration

Danaher

1d•Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible.

Requirements

Bachelor's degree and minimum 15+ years’ work experience in a Quality or Regulatory Assurance related field including medical devices.
Comprehensive knowledge of Quality Systems, which ensure that products, processes, and services consistently meet or exceed the desired quality standards, including compliance to ISO 9001, ISO 10993, FDA 21 CFR Part 820 and ISO 13485, MDR, MD-SAP and other relevant medical country specific requirements.
Working knowledge of manufacturing processes, product assembly, materials and properties.
Demonstrated understanding of root cause analysis, corrective and preventive action (CAPA), change control, verification and validation methodologies, manufacturing/production process control methodologies, risk management, and continuous improvement in a medical device environment.
Demonstrated knowledge of Quality Management System tools and ability to effectively communicate within all levels of the organization.
10+ years of people leader experience, preferably globally.

Nice To Haves

Continuous improvement processes and operational excellence

Responsibilities

Partner with the Global QARA leaders and the Filtration leadership to drive functional initiatives, supportive of the business priorities, enabling business strategy and growth.
Accountable for setting and monitoring Quality KPI's to include, reporting on performance/trend insights through business reviews. Further drive KPI implementation across all sites, operations, and functions.
Manage the quality system which provides guidance, tracking, and metrics of compliance. Further develop and lead audit/inspection readiness activities to meet compliance and regulatory requirements.
Lead through DBS, driving functional efficiencies and improvement development of the QMS, QA processes, and QA support function/organization.
Lead the global team across all Filtration QARA functions and sites. Assume all functional responsibilities including people development, performance, supplier quality, and financial responsibilities.