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 (GPO) Quality Assurance for Beckman Coulter Diagnostics is responsible to oversee the development, governance and integration of the Corrective and Preventive Action (CAPA) process into our global Quality Management System (QMS) in all aspects of the business, including identification and implementation of continuous process improvement activities. In addition, the CAPA GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB).

This position is part of the Global Quality System and Compliance Group located in Brea, California, USA 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 Global Process Owner (GPO) Team and report to the Senior Manager of Global Quality responsible for overseeing various Global Quality Management System elements. If you thrive in a fast-paced, innovative, influential role and want to work to build a world-class Global Quality System and Compliance 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, European Union Medical Device Directives (MDD), and In-Vitro Medical Device Regulation (IVDR) as well as all other applicable global regulatory requirements.
• Maintain oversight, tracking, metric reporting and escalation of issues while providing consultation and support for the Corrective and Preventive Action (CAPA) process, ensuring process is maintained per company policies and industry standards.
• Function as a global representative during Agency /3rd Party Audits and assists in the preparation and submission of audit responses and requests for information to FDA, MDSAP Notified Body and other Regulatory Bodies.
• Utilize Danaher Business System (DBS) tools to drive compliance, effective processes, and continuous process improvement. Solves unique and complex problems with broad impact on the business; utilizing conceptual and innovative thinking to develop solutions.
• Collaborate across the organization at all levels. Building working relationships with various geographies, business units, sites and functions throughout the world, communicating complex ideas, anticipating potential objections and persuading others, often at senior levels, to adopt a different point of view.

The essential requirements of the job include:

• A bachelor’s degree with 14+ years of experience or master’s degree with 12+ years of experience or Doctoral degree with 9+ years of experience, preferably in areas of medical devices, engineering, or quality assurance.
• Strong knowledge of Quality, Regulatory compliance, and operations systems and processes, including GMP and QSR requirements for medical devices. (ISO13485, FDA’s QSRs, EU’s MDD, Canadian Regulations) is required. Proficiency in the Microsoft Office suite of products is required. American Society for Quality certification is preferred.
• Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations.

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

• Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
• Expert understanding of