CAPA Management and Post Market Surveillance Reporting

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At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

The CAPA Management and Post Market Surveillance Reporting for Beckman Coulter Diagnostics is responsible for leading strategic quality improvement initiatives and ensuring regulatory compliance in CAPA and PMS systems at the Miami site.

This position is part of the R&D – Quality Assurance/Validation located in Miami, Florida, and will be on site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Quality Assurance team and report to the CAPA/PMS/MasterControl Senior Manager responsible for CAPA/PMS/MasterControl in US. If you thrive in a fast-paced, cross-functional, leadership role and want to work to build a world-class quality and compliance organization—read on.

In this role, you will have the opportunity to:

• Lead the implementation and advancement of CAPA and PMS systems aligned to global quality objectives & coordinate with global teams and executive stakeholders on CAPA/PMS strategy and escalations
• Analyze complex quality data using tools like Tableau and Spotfire to identify trends and drive corrective actions
• Chair the CAPA Review Board and oversee governance, traceability, and accountability for site CAPAs
• Serve as subject matter expert (SME) for internal and external audits regarding CAPA and PMS systems
• Champion continuous improvement using DBS tools such as Kaizens, Value Stream Mapping, and KPI frameworks

The essential requirements of the job include:   

• Bachelor’s or Master’s degree in a scientific or engineering discipline
• Long-standing experience (9+ years) in regulated industry roles, specifically in CAPA, PMS, or QMS program ownership
• Demonstrated expertise in quality systems tools (SmartSolve), analytics platforms (OBI, Tableau), and DBS methodologies
• Proven success in cross-functional leadership and audit preparedness
• Strong communication skills with experience presenting to executive leadership

It would be a plus if you also possess previous experience in:

• Experience with business intelligence tools such as Spotfire
• Spanish language skills

The salary range OR the hourly range for this role is $115,000 – $140,000 USD annually. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer 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.

Spanish is a plus.

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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.