Manager, Manufacturing Quality

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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 Quality is responsible for providing management of Cepheid's Quality Engineering team to ensure appropriate quality levels across the IVD product families. Formulate and drive manufacturing quality excellence programs designed to assure maintenance of the Company's competitive position and profitability of its manufacturing operations. Collaborate cross-functionally, assuring goal alignment, with other members of the senior management team to include Marketing, Business Development, Sales, Operations, Engineering, Program Management, and Regulatory Affairs & Quality Systems.

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

In this role, you will have the opportunity to:

• Independently plan, coordinate, and report on product quality programs that provide a basis for sound technical decisions using techniques in design of experiments and data analysis. Effectively employ Danaher Business System (DBS) tools and Lean Manufacturing concepts to maximize efficiency and quality. Generates, analyze, prepares and issue complex data for assigned quality reports.

• Review, implement, or revise product, project, and program quality activities. Approve the design, implementation, and schedule for QE projects. Initiate, recommend, and provide training for QE personnel. Drive improvements in process capability and quality of products.

• Create validation master plans and risk management plans, facilitate risk assessments, and perform activities related to new product development, process qualification/validation, and factory expansion projects. Ensures maintenance of the validated state of manufacturing processes and consideration for re-validation during various design and process changes. Reviews change orders and deviations according to guidelines. Ensure the impact of change(s) is accurately assessed and that all required activities are performed.

• Supports global initiatives/QSIPs and ensure that required activities are carried out, including pertinent personnel planning, training, and resourcing. Creates and implement local and global standard operating procedures and work instructions.

• Regularly monitors, investigate and review non-conformance activities. Proactively recommends and implements process improvements to reduce the number of non-conformances and improve responsiveness and cycle time performance for CAPA and NPI processes. Drives and facilitates the Problem-Solving Process to solve complex problems.

• Apply advanced technical experience, skill and performance to the oversight of multiple projects to achieve strategic goals. Work cross-functionally and frequently consult with Manufacturing, Engineering, Research and Development, Quality, Regulatory, Marketing, and other functional groups. Routinely communicates project goals, status, requirements, and deliverables to Quality Management.

The essential requirements of the job include:

• Bachelor's degree in an engineering discipline, 6+ years of Quality Engineering experience and 3+ years of team and associate management experience

• Broad extensive knowledge of methods, processes, equipment, and techniques in manufacturing, quality, development and engineering

• Experience in the application of production and process controls, including process validation and quality control tools

• In-depth knowledge of Quality standards (GMP, ISO 9000, ISO13485, etc.) and experience in the medical device industry, knowledge of CFR 21 Part 820

• Knowledge of high volume, state of the art manufacturing processes, preferably in the medical device industry. The ability to present complex theoretical concepts and empirical scientific data effectively and concisely

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

• Work experience should include 3-6 years in leading and/or supporting Operations in post-market and NPI projects.

• A quality management certification from the American Society for Quality (ASQ) or other qualifying organizations.

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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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 fully 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 to request accommodation.

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