Quality Manager

Need flexibility in shift from Mon-Fri and Tue-Sat alternating Quality Manager 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 Quality Manager is responsible for performing and supporting Quality assurance and Quality Systems activities.

This position supports Operations activities such as non-conformance investigations and dispositions, CAPA requests, and is responsible for the maintenance of Quality System documentation as related to batch record compliance and ensuring accuracy and traceability of data and in accordance with the requirements of FDA’s Quality System Regulation (QSR) and ISO 13485(ISO).

This position will learn and Drive/ facilitate the Problem-Solving Process to solve complex problems and will be able to drive process improvement projects within the department.

Growth and development opportunities in this group are driven by our core values and Danaher policies.

This position is part of the Quality Organization and will be in Newark, CA.

Our mission is to ensure that performed Quality Systems activities are done by focusing on the quality of the product, the internal and external customer needs, and according to the Quality System, FDA, and ISO regulations.

In this role, you will have the opportunity to: Originate and implement local and global standard operating procedures and work instructions.

Regularly monitor, investigate and review non-conformance activities and generate CAPAs based on trends/issues identified from operations, MRB and drive them to closure.

Proactively identify potential problems and drive continuous improvement, utilizing the CAPA and other processes.

Drive and facilitate the Problem-Solving Process to solve complex problem.

Responsible for the hiring, training and development of Quality assurance personnel.

Accountable for batch records review and documents, for completeness and compliance with QSR and ISO requirements to support release of raw materials, work in progress and final products.

This includes reagents, components, and instrumentation-related products.

The essential requirements of the job include: Bachelor’s Degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 8 years of related Quality experience OR Master’s degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 6 years related Quality experience.

Experience in Design Control, Validation Process, Non-conformance process, MRB, and CAPA process.

Experience with Device History record review and sign off process.

Experience representing their department during Internal and External Quality system audits.

Work experience should include 3 years in Technical management.

Medical Device or Clinical Laboratory experience.

Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485.

It would be a plus if you also possess previous experience in: Medical Assays and Instruments 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.

LI-LH2 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 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 applyassistancedanaher.com to request accommodation.

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