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- Tasks: Lead a global team to ensure top-notch quality assurance in filtration.
- Company: Join a leading medical device company committed to quality and innovation.
- Benefits: Competitive salary, bonuses, comprehensive health benefits, and generous paid time off.
- Other info: Opportunity for global travel and professional development in a dynamic environment.
- Why this job: Make a significant impact on product quality and drive business growth globally.
- Qualifications: 15+ years in Quality Assurance with strong leadership and regulatory knowledge.
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.
What You Will Do
- 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.
Who You Are
- 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.
Travel, Motor Vehicle Record & Physical/Environment Requirements
- Ability to travel – 30% – 50% global travel per business needs.
- It would be a plus if you also possess previous experience in 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.
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.
Senior Director Quality Assurance Filtration in Little Chalfont employer: Cytiva
Contact Detail:
Cytiva Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director Quality Assurance Filtration in Little Chalfont
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in Quality Assurance or Filtration. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by researching the company’s quality standards and recent projects. Show us you’re not just another candidate; demonstrate your passion for quality assurance and how you can contribute to their growth.
✨Tip Number 3
Practice your pitch! Be ready to explain how your 15+ years of experience aligns with their needs. Highlight your knowledge of ISO standards and your leadership skills to make a lasting impression.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Senior Director Quality Assurance Filtration in Little Chalfont
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Senior Director Quality Assurance Filtration role. Highlight your experience in quality systems and regulatory compliance, as these are key for us.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're the perfect fit for this position. Share your passion for quality assurance and how your background aligns with our goals at StudySmarter.
Showcase Your Leadership Skills: Since this role involves leading a global team, be sure to highlight your leadership experience. Share examples of how you've developed teams and driven improvements in quality management systems.
Apply Through Our Website: We encourage you to apply directly through our website. This ensures your application gets to the right people quickly and helps us keep track of all applicants efficiently.
How to prepare for a job interview at Cytiva
✨Know Your Quality Standards
Make sure you brush up on the key quality standards relevant to the role, like ISO 9001 and FDA regulations. Being able to discuss these in detail will show that you’re not just familiar with them, but that you can apply them effectively in a real-world context.
✨Showcase Your Leadership Experience
With over 10 years of people leadership experience required, be ready to share specific examples of how you've developed teams and driven performance. Highlight your global experience and how you've managed diverse teams across different locations.
✨Prepare for Technical Questions
Expect questions around root cause analysis, CAPA, and risk management methodologies. Prepare to discuss your approach to these processes and provide examples of how you've successfully implemented them in past roles.
✨Demonstrate Your Strategic Thinking
This role is about driving functional initiatives that align with business priorities. Be prepared to discuss how you've previously aligned quality assurance strategies with broader business goals, and how you plan to do this in the future.