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Senior Quality Operations Engineer

Company: Danaher
Location: Sunnyvale
Posted on: June 10, 2021

Job Description:

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert System, we've taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most.

Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at or follow us on Twitter (@CepheidNews).

Key responsibilities

  • Generate, prepare and issue sophisticated data for assigned quality reports.
  • Provide recommendations in Customer Feedback failure investigations.
  • Review, implement, or revise product, project, and program quality activities.
  • Approve the design, implementation, and schedule for QA projects.
  • Recommend appropriate field actions to product regulatory committees.
  • Resolve issues of experimental design and data discrepancy in both intra and interdepartmental experiments.
  • Support project core teams throughout the phase gate process for new product development and ensure compliance to Cepheid and Danaher policies and procedures.

As a Senior Quality Operations Engineer, you will support multi-functional teams by providing design verification of a modified bioreactor system's user requirements, functional specifications and product accompanying documentation. You will select and/or develop test requirements and protocols for the modified products, and you will be trusted with independently advising and executing test activities to ensure product quality and regulatory compliance. The key responsibilities for this role include:

  • Assure project adherence to Design Controls to deliver robust, manufacturable products which meet the defined delivery timeline, design inputs and quality metrics to meet business unit goals.
  • Identify and drive countermeasures in instances when deviations to the project plan occur.
  • Mentor and develop extended Quality team members as necessary to assure common understanding of the product development process and project goals
  • Effectively communicate and maintain visual tools for project tracking and management
  • Effectively employ Danaher Business System (DBS) tools and concepts to maximize efficiency and quality.
  • Typically serves as a project or team leader for a complex business concept or application.
  • Influence the development of others as project leader.
  • Works with team members to develop team goals and plans, resolve problems and achieve goals.

Knowledge and skills:

  • Proven track record with system and or reagent product development
  • Readily accepts responsibility and accountability for project success and key decisions
  • Strong background and experience in NPI Quality for instrumentation hardware and qualification.
  • Experience in the application of production and process controls including process validation, process control plans and statistical process control.
  • Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
  • Advanced experience with risk management and design control principles
  • Experience representing their department during quality system audits.
  • Self-starter with a proven ability to focus efforts, overcome obstacles and complete key projects
  • Ability to work effectively in a team environment and build strong working relationships.
  • Experience in troubleshooting and responding to customers concerns
  • Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.
  • Cultivate an environment that values diversity and inclusion.
  • Strong attention to detail. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).
  • High degree of initiative and self-motivation.
  • Strong analytical and problem-solving skills.
  • Proficient with Microsoft Office (Word, Excel, PowerPoint).


  • Bachelor's degree in field with 5+ years of related work experience OR
  • Master's degree in field with 3+ years of related work experience OR
  • Doctoral degree in field with 0-2 years of related work experience

Preferred qualifications:

  • Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820 is strongly desirable.
  • A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples include the CQE, CRE, CQA, etc.
  • Certified in Lean manufacturing and/or Six Sigma
  • Experience in product mechanical evaluation & testing and GD&T
  • Hands-on experience in advance statistical analysis
  • Experience in injection plastic molding processes

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

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 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 202.419.7762 or to request accommodation.

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

Keywords: Danaher, Sunnyvale , Senior Quality Operations Engineer, Other , Sunnyvale, California

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