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Director, Quality Control

Company: Cepheid
Location: Lodi
Posted on: November 23, 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 Director, Quality Control and Quality Assurance is responsible for provide management and overall strategic direction and operational coordination of activities for Quality Control and Quality Assurance Operations. - The Director, QC/QA will ensure compliance with FDA QSR, ISO 13485:2016, and other applicable global regulatory requirements and alignment with company objectives and Quality Standards. The Director, Quality Systems will report directly to the Senior Director, Quality Systems (Site Quality Leader) and will supervise the Lodi, CA Quality Control and Quality Assurance functions.

This position is part of the Quality Operations and will be located in Lodi California.

In this role, you will have the opportunity to:
Build, develop and manage a high performing Quality team including Quality Control and Quality Assurance
Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management
Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
Drafts, reviews, and approves Standard Operating Procedures (SOP), sampling plans, specifications, protocols and reports related to product/processes, equipment, method, validation. - This includes deviation investigations and reporting
Support development of QC analytical methods. - Works in conjunction with other departments to develop, qualify, and transfer QC analytical methods
Develop resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations
Lead employee development, communication and training programs in connection with the company's strategic goals, quality objectives, and operational systems

The essential requirements of the job include:
Bachelor's Degree in Engineering, Biology, Biochemistry, or related field with 14 years of related experience and at least 4 - years of Supervisory or Department Lead experience in managing both processes and resources
Medical Device industry experience, preferably IVD with expert knowledge of US FDA and ISO requirements
Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
Track record of measurable, operational improvements to Quality Systems related functions.
DBS, LEAN or Six Sigma operational excellence training or certification

It would be a plus if you also possess previous experience in:
Seven years of Department Leadership experience in managing both processes and resources.
Training and certificates in quality or regulatory affairs (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
Experience in Manufacturing Operations preferably in molecular diagnostics

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.

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#Lodi

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, Lodi , Director, Quality Control, Executive , Lodi, California

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