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Danaher Corporation Senior Manager, Manufacturing Quality in Lodi, California

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 (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Senior Manager Manufacturing Quality is responsible providing management oversight of Cepheid’s Manufacturing Quality Operations Quality Engineering teams and activities to ensure appropriate quality levels across the 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, 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:

  • Lead Manufacturing Quality Engineering team to ensure Cepheid’s quality standards are consistently achieved and maintained. Ensure that processes are sufficiently capable to deliver and maintain Cepheid’s quality standards, and develop action plans using cross functional teams to address weaknesses or deficiencies. Develop and implement policies and processes to ensure Cepheid’s quality standards are detailed, robust, communicated and measured consistently throughout internal manufacturing sites and external suppliers

  • Critically analyze, using appropriate sources of data, Cepheid’s operations capabilities; setting strategy, structure, and processes to drive sustained quality improvement in local manufacturing facility

  • Effectively deploy Danaher Business System (DBS) tools and concepts to maximize process efficiency and effectiveness

  • Develop world class, common systems for completely integrating Quality Management Systems with Operational processes and the Cepheid’s Operating System. Develop key metrics and scorecards to measure quality level performance within the manufacturing facility

  • Align site and quality objectives with the Business Plan, Operations Objectives, and the Global Manufacturing Quality System to assure effective and efficient use of resources and manufacturing quality excellence

  • Set facility level Quality operations goals and objectives for customer focused quality initiatives. In particular, analyze customer complaint trend data and set strategies, structure and processes to drive improvements in operations quality

  • Collaborate with NPI teams to ensure that quality attributes, manufacturability and lessons learned from existing products (e.g. production performance, quality problems, complaints) are integrated into the design and manufacturing processes

  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site)

  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement

The essential requirements of the job include:

Education and Experience (in years):

  • Bachelor’s degree with 12+ years of related work experience OR

  • Master’s degree in field with 8 years of related work experience

  • 4 years of people management Experience

Knowledge and skills:

  • Extensive experience in manufacturing quality with people management experience.

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

  • Expertise with the domestic and international medical device regulatory environment including the CE Mark, 510(k)/PMA process and approvals, FDA audits and review, design control documentation and internal guidelines

  • Intermediate to advanced skill level of Minitab, MS Word, Excel, Access, Auto Cad or equivalent

  • In-depth knowledge 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

  • Effective leadership skills and ability to influence department and peers, as well as be a team player

  • Fosters an environment that values diversity and inclusion

  • Excellent verbal & written communication skills (internal & external customers)

  • Knowledge of finance and accounting business functions

  • Multi-site and multi-regional research and development leadership exposure and success

  • Lean Six Sigma experience required, greenbelt or blackbelt strongly preferred

  • Able to apply strategic thinking

  • Excellent attention to detail, flexible and adaptable to change

  • Able to operate under pressure, multitask, set priorities and meet deadlines

  • Must exhibit strong leadership skills, both with subordinates and peers, with emphasis on relationship development and implementation of company culture improvement initiatives

  • Must have excellent written and oral communication abilities including:

  • The ability to present complex theoretical concepts and empirical scientific data effectively and concisely

  • The ability to articulate clearly and engage in dialogue with all levels within the organization

  • Must be able to influence with others in a fast-paced, cross-functional, matrixed organization

  • Strong analytical and technical skills

  • Motivated self-starter, capable of achieving objectives in a demanding environment

  • Extremely detail-oriented, accurate, and highly organized

  • Excellent problem-solving skills and judgement

  • Requires excellent interpersonal and communication skills. Ability to work well with people. Ability to interface successfully with various departments and be a part of their teams

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

  • Black Belt or Master Black Belt Certification

  • Lean Certification

  • PMP Certification

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.

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 (https://www.danaher.com/how-we-work/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 (https://www.dol.gov/agencies/ofccp/posters) .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 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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