Senior Staff Global Process Owner Quality Assurance

Wondering what's within Beckman Coulter Diagnostics? Take a closer look.

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 Senior Staff Global Process Owner Quality Assurance for Beckman Coulter Diagnostics is responsible for ensuring service documentation outputs are meeting our quality and regulatory standards.

This position is part of the Post Market Surveillance department located in Brea, CA and will be fully remote. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Service Quality Assurance team and report to the Senior Manager Quality Assurance responsible for ensuring Service quality and regulatory compliance. If you thrive in a fast-paced role and want to work to influence the creation of a world-class service quality organization-read on.

In this role, you will have the opportunity to:
Maintain global policies, procedures, and work instructions to ensure compliance with local, state, and federal environmental regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, and European Union Medical Device Directives (MDD) as well as all other applicable global regulatory requirements.
Provide oversight on service process, report on Key Performance Indicators (KPI) to Beckman Coulter leadership, and escalate issues with service and installation process, and take action to ensure processes are maintained per company policies and industry standards.
Develop and implement tactical plans to meet Beckman Coulter and Post Market Surveillance objectives and support the development and implementation of policies to ensure compliance with applicable worldwide regulations.
Build working relationships with service organization, commercial QRA, complaint handling teams (Complaints), product management (feedback), industry etc. to ensure process solutions are compliant, efficient, and adaptable to various geographies, business units, sites, and functions throughout the world.
Maintain up-to-date knowledge on changes to regulations and industry standards to ensure proactive compliance to worldwide standards and requirements specifically as related to medical device industry and quality system regulations.
The essential requirements of the job include:

Bachelor's Degree or greater in Biomedical Engineering or closely related field
Minimum 14+ years with bachelor's degree or master's degree with 12+ years of relevant medical device industry experience. Preferrable 5+ years of experience within a Service organization.
8+ years of experience working withi a Quality Management System.
Knowledge of domestic and international quality systems standards such as FDA 21 CFR Part 820 and ISO 13485
It would be a plus if you also possess previous experience in:

DBS Fundamentals Certified Practitioner
ASQ Internal Auditor or CQE Certification

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

The salary range for this role is $150,000-$160,000 USD. 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. We may ultimately pay more or less than the posted range. 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.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. 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.