Senior Director Quality Assurance Filtration

Danaher•Marlborough, MA

21h•Onsite

About The Position

The Senior Director Quality Assurance Filtration will partner globally with internal and external stakeholders to manage a world-class Quality Assurance program for the Filtration business to enhance growth. This role will report into the VP Quality Assurance for Cytiva and will further support the Filtration, VP & GM, and will be part of both leadership teams. The work arrangement for this role will be onsite. The Senior Director will partner with the Global QARA leaders and the Filtration leadership to drive functional initiatives, supportive of the business priorities, enabling business strategy and growth. This role is 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.

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

Previous experience in 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.