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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 Scientist II for Beckman Coulter Diagnostics is responsible for providing quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and compliance with government regulations, industry, and OpCo standards. May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring, and supplier development. May manage process and product non-conformances in line with company procedures. Quality assurance tests may be conducted to ensure product specifications are met. May review, investigate, resolve, and report on quality discrepancies. May develop, maintain, monitor, and audit quality management systems and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards. May monitor, investigate, and report on customer complaints. May obtain the necessary quality system certifications and licenses (e.g., ISO, CE) to support market release of new product development. May lead audit and inspection preparation and resolution of audit and inspection findings. They may have frequent interactions with other functional areas and operating entities.

This position is part of Quality Assurance in Carlsbad, CA, and will be on-site. At Beckman Coulter, our vision is to reimagine healthcare, one diagnosis at a time relentlessly.

You will be part of the Quality Assurance team and report to the QA/QC Manager responsible for line support, Project QA groups, and Quality Control. If you thrive in a multi-functional, fast-paced role and want to work to build a world-class Quality Assurance organization, read on.

In this role, you will have the opportunity to:

• Review and approve document changes, validations, non-conformances, design changes, out-of-specification (OOS), and other quality documents.

• Ensure company, industry, and regulatory standards are met, e.g., ISO 13485, 21 CFR 820, MDSAP, IVDR, and Beckman Coulter's Quality Policies and SOPs.

• Serve as QA team member on multi-department diagnostic projects for process improvement.

• Review and update Standard Operating Procedures.

• Other duties may include external audit support, productivity, and quality improvements through leading kaizens.

The essential requirements of the job include:

• Bachelor’s degree in chemistry, Biology, or related field with 5+ years’ experience OR master’s degree in chemistry, Biology, or related field with 3+ years’ experience.

• Experience in quality and quality assurance in a medical-regulated industry (ISO13485, 21 CFR 820, IVDR)

• Strong analytical, problem-solving, and technical writing skills (non-conforming records, CAPAs, complaints, audit observations)

• Understanding risk management best practices and regulations for the medical device industry.

• Knowledge of Lean tools or other continuous improvement tools

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

• Experience with diagnostic reagents for general chemistry and immunochemistry

• Understanding of root cause analysis, risk management, FMEA, validation, and design controls

• Knowledge of Lean tools or other continuous improvement tools

The salary range for this role is $70,000 – $90,000 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. 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.

The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .

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 applyassistance@danaher.com to request accommodation.