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 Quality Assurance Manager (Quality Control) for Beckman Coulter Diagnostics is responsible for overseeing and providing strategic management direction to accomplish organizational and project milestones initiating within the West Coast North America Reagent Operations.

This position is part of the Quality organization located in Carlsbad, CA and will be hybrid. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Carlsbad Quality Assurance team and report to the Director of Quality responsible for associate growth and development and partnership with operations teams. If you thrive in a fast-paced, high performing organization and want to work to build a world-class quality organization—read on.

In this role, you will have the opportunity to:

• Lead company performance key quality indicators and influence others to drive improvements both through direct and indirect or informal reporting structures.
• Manage, engage, and develop the talent of the team by training, coaching and model behavior to create a high-functioning organization; including developing resourcing strategies and allocating budgets.
• Lead a team of professional associates and supervisors to accomplish organizational deliverables and identify and solve complex problems through leveraging resources internal and external to the team for long-term improvements
• Monitor organizational progress at a high level while empowering a team to ensure compliance to quality systems with adherence and integrity in a regulated environment through compliance to all FDA, QSR/cGMP, ISO and Quality Policies of Beckman Coulter.
• Utilize Danaher Business System (DBS) tools to drive compliance, effective processes and harmonization of Quality process improvement, shared objectives with Operations partners and processes between all sites within scope.

The essential requirements of the job include:

• Bachelor’s degree with 9+ years of experience or Master’s degree with 7+ years of experience.
• Proven progressive track record with quality control and quality assurance (final product release testing, inspections, non-conformance, etc.)
• 2+ years leading teams and managing people
• Experience in an FDA-regulated environment utilizing regulations associated with Supplier Quality, Quality Assurance and Quality Control.

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).
• Strong understanding of quality systems methodology and applications, especially those related to medical device manufacturing (nonconforming product, post-launch cesign change, supplier management).
• Possess a broad knowledge of surrounding areas including Quality Systems, Development Quality and Regulatory

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

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.

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

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.