Quality Assurance Lead

2 weeks ago


Lodi, United States Cepheid Full time

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 Assurance Lead is responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485 (ISO). This person will lead and participate in interdepartmental initiatives and opportunities for continuous improvement and generating standard operating procedures.

This position is part of the Quality Department and will be in Lodi California. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

Review batch records to support the release of finished goods, raw materials, and purchase specs for completeness/compliance with QSR and ISO requirements. Be responsible for ensuring Associates are appropriately trained to perform job tasks and facilitate process improvement within other departments, using training, coaching, and team participation. Assists Supervisor in resolving problems by analyzing data; investigating issues; identifying solutions; recommending actions, determining the appropriate approach for new assignments, and supporting Lean Manufacturing initiatives.

The essential requirements of the job include:

High School degree (or equivalent experience) with 4-6 years of related work experience OR AA or Technical Degree with 2-4 years of related work experience. Excellent verbal and written communication skills in group or one-on-one settings with computer skills, e.g., word, excel, and electronic documentation systems.

This position requires a 12-hour shift (6pm - 6am) with an alternating 3-day/4-day work schedule.

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.

The salary range OR the hourly range for this role is . 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 a 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.



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