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Senior Investigations Specialist, Systems

Company: Cepheid
Location: Sunnyvale
Posted on: November 16, 2021

Job Description:

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the - Danaher Business System -which makes everything possible.

The -Senior Investigations Specialist, Systems is responsible -for independently investigating complaints ranging from moderately difficult to complex; - conducting research; developing reports of findings and recommendations and more.

This position is part of the -Quality and Regulatory Affairs Department -and will be located in -Sunnyvale, CA.

In this role, you will have the opportunity to:
Provide support to the product complaint system through; leading, and managing product complaint investigations, performing data analysis, and trending of complaint information to detect signals, and take appropriate actions in a timely manner

Lead cross functional investigation efforts in area of systems instrumentation.

Partner with Sustaining Engineering and Assay FI teams to help drive root cause for complaints

Keep the complaints database updated, as soon as, factual information is available and summarize closed investigations into the database accurately

Support new product surveillance procedures and activities

Ensure compliance to 21CFR820, ISO 13485, and other quality systems regulations and regulatory standards, as applicable.

Participate in Quality Systems activities including support product complaints associated CAPAs

--- The essential requirements of the job include:
Bachelor's degree in field with 5+ years of related work experience

Principles, methods and techniques of data analysis and complaint trending

Must have experience in investigations and root cause analysis

Must have experience managing critical investigations

Interprets subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.

Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at - danaherbenefitsinfo.com .

When you join us, you'll also be joining Danaher's global organization, where 69,000 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 is committed to a diverse and inclusive culture where everyone feels they -belong -and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.

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

When you join us, you'll also be joining Danaher's global organization, where 69,000 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 require all US and Puerto Rico employees to be vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.

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 applyassistance@danaher.com to request accommodation.

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

Keywords: Cepheid, Sunnyvale , Senior Investigations Specialist, Systems, Other , Sunnyvale, California

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