Senior Failure Investigation Analyst

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 Failure Investigation Analyst for Beckman Coulter Diagnostics is responsible for the investigation of manufacturing and distribution non-conformances that may impact product quality at the Sacramento site.

This position is part of the reagent manufacturing team located in West Sacramento, CA 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 Microbiology Operating team and report to the Process Engineering Manager responsible for ensuring that every patient has access to the right antibiotic treatment at the right time. If you thrive in a fast paced role and want to work to build a world-class medical manufacturing organization-read on.

In this role, you will have the opportunity to:

• Lead and resolve Internal Non-conformance investigations (assessment of non-conforming product, root cause analysis, corrective, and preventative actions)
• Lead and resolve customer manufacturing related CAPA and Post Launch Risk Assessments
• Provide technical support for Operations (Design of experiments, technical writing, analytical testing (HPLC, UV-Vis Spectroscopy, and bioassay)
• Supports Operations projects (validation and design change)
• Provide training and mentorship within operations
• Risk management, process validation, design of experiments, and design change
• Leading continuous improvement efforts, in a manufacturing environment

The essential requirements of the job include:

• Bachelor's degree in related science field with 5+ years of experience OR Master's degree in related science field with at 3+ years of experience OR Doctoral degree in related science field with 0+ years of experience
• Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams.
• Ability to drive results, foster teamwork, handle pressure, and provide feedback
• Must be able to demonstrate skills in root cause investigation and problem solving
• Must have critical thinking skills and good judgment working in an independent environment

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

• Non-conformance assessment, root-cause analysis, and CAPA
• Working with medical device quality systems in compliance with US FDA regulations (21 CFR) and ISO 13485
• Experience in Microbiology

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.

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.

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.

If you've ever wondered what's within you, there's no better time to find out.