Manager, Manufacturing Software Quality at Cepheid in Sunnyvale, California

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 Manager, Manufacturing Software Quality provides technical and managerial guidance to highly skilled individual contributors and reinforces technical direction of the group. Ensures projects are completed on time within budget and manages the development of processes and procedures to implement functional strategies. Resolves operational problems through collaboration with other managers and coordinates resources to meet operational objectives within their area.

This position is part of the Systems Quality department and will be located in Sunnyvale, CA. At Systems Quality, our vision is to deliver quality products to our customers.

In this role, you will have the opportunity to:

• Act as an advisor to direct reports, and may become actively involved, as required, to meet schedules and resolve problems.


• Receive assignments in the form of objectives with goals and the process by which to meet goals.


• Provide direction to employees according to established policies and management guidance.


• Administer company policies that directly affect associates, recommends changes to policies, and management reviews work to measure meeting of objectives.


• Be responsible for design transfer activities to Instrument Manufacturing Software


• Interact with other supervisors and functional peer groups, with the Interaction normally requiring the ability to gain the cooperation of others.


• Drive continuous improvements with changes in business needs, new and updated changes in guidelines from FDA and other regulatory agencies.

The essential requirements of the job include:

• BA/BS degree with 5+ years of working experience in regulated industry and minimum of 2+ years' experience in managing complex projects or master's degree with 3+ years of experience


• Proficiency and working knowledge in Process controls, ISO-14971, 21CFR Part11 and ISO-13485 regulations.


• Experience in cultivating and maintaining contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks.


• Experience in proactively identifying and prioritizing opportunities to streamline testing and/or quality and ensure compliance.


• Must have experience with Windows environments, Excel macros and/or complex spreadsheets, and SQL or other RDBMS systems.

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

• Quality Engineering certification from American society for quality (ASQ) or other qualifying organizations such as CRE, CQA.


• Experience working with software tools such as Agile, Complaint tracking, requirements management, defect tracking systems.

The salary range for this role is $103,000 - 141,600. 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.

Cepheid, a Danaher operating 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

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.

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.