Senior Director Quality Assurance Filtration

Senior Director Quality Assurance Filtration

Senior Director Quality Assurance Filtration will partner globally with internal and external stakeholders to manage a world‑class Quality Assurance program for the growth of the company. This role reports into the VP Quality Assurance and supports the Filtration VP & GM. The work arrangement for this role is onsite.

• 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.

• Bachelor's degree and minimum 15+ years of work experience in a Quality or Regulatory Assurance related field including medical devices.
• Comprehensive knowledge of Quality Systems that ensure products, processes, and services consistently meet or exceed quality standards, including compliance to ISO 9001, ISO 10993, FDA 21 CFR Part 820, 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.

• Ability to travel – 30% – 50% global travel per business needs.

• Continuous improvement processes and operational excellence.

The annual salary range for this role is $215,000 – $250,000. This range may be modified in the future. This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note:

No amount of pay is considered to be wages or compensation until such amount is earned, vested and determinable. The amount and availability of any bonus, commission, benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or other characteristics protected by law. The U.S. EEO posters are available 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: or