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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.
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The Snr Director – U&FM QA is responsible for leading the Quality function within the HWS OpCo BU partnering with Customers, Product Management, R&D and Operations to meet business objectives and drive longterm growth
This position reports to the VP QARA Hardware Solutions and is part of the Cytiva Bioprocess HWS QA/RA Leadership Team located in Duncan, SC/Medemblik, Netherlands and will be an on-site role.
What you will do:
- Partners with the BU GM and their Leadership Team, Cytiva QARA leadership and related stakeholders to drive functional initiatives, supportive of the business priorities, enabling the business strategy & growth.
- Collaborate, lead and support customers on both short and long term quality initiatives and escalations acting as the voice of the BU and Cytiva as required
- Responsible for setting & monitoring Quality KPI's including, reporting on performance/ trend insights within business reviews
- Ensure critical business challenges are escalated and addressed and adapt strategic and daily management (DM) plans accordingly
- Lead critical PSP’s and manage PD level activities
Who you are:
- Bachelor's degree and minimum 10+ years’ work experience in a Quality or Regulatory Assurance related field.
- 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.
- 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.
- Proven Strong leadership skills. With 10+ Yr people leader experience, preferably globally
Travel, Motor Vehicle Record & Physical/Environment Requirements:
- Ability to travel internationally at short notice and up to 50%
- Must have a valid driver’s license with an acceptable driving record
- Ability to be site based and enter and exit cleanrooms/production spaces on a regular basis
It would be a plus if you also possess previous experience in:
- Operations, R&D, Engineering or other related functions.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
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:1-202-419-7762 or [email protected].
Skills Required
- Bachelor's degree and minimum 10+ years' work experience in a Quality or Regulatory Assurance related field
- Comprehensive knowledge of Quality Systems and compliance to ISO and FDA regulations
- Working knowledge of manufacturing processes and risk management
- Strong leadership skills with global experience
Beckman Coulter Diagnostics Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Beckman Coulter Diagnostics and has not been reviewed or approved by Beckman Coulter Diagnostics.
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Healthcare Strength — Healthcare coverage is described as comprehensive, including medical, dental, vision, life and disability insurance, flexible spending accounts, and mental health support. Feedback suggests these offerings are a notable strength of the overall package.
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Leave & Time Off Breadth — Paid time off, paid holidays, sick days, and volunteer time are highlighted, with flexibility or remote arrangements available for some roles. Feedback suggests this breadth of time-off options contributes meaningfully to total rewards.
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Parental & Family Support — Paid parental leave is provided for birth, adoption, or foster placement with the ability to use time in flexible increments within the first year. Feedback suggests family-focused perks like adoption support add tangible value for caregivers.
Beckman Coulter Diagnostics Insights
What We Do
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
