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
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 www.cepheid.com or follow us on
- Generate, prepare and issue sophisticated data for assigned
- Provide recommendations in Customer Feedback failure
- Review, implement, or revise product, project, and program
- Approve the design, implementation, and schedule for QA
- Recommend appropriate field actions to product regulatory
- 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
- 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
- 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
- Experience representing their department during quality system
- 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
- Ability to identify, analyze and solve problems with minimal
direction and make decisions with confidence.
- Cultivate an environment that values diversity and
- Strong attention to detail. Ability to successfully balance and
prioritize multiple ongoing projects/tasks (Project Management
- High degree of initiative and self-motivation.
- Strong analytical and problem-solving skills.
- Proficient with Microsoft Office (Word, Excel,
- Bachelor's degree in field with 5+ years of related work
- Master's degree in field with 3+ years of related work
- Doctoral degree in field with 0-2 years of related work
- Good understanding of the following QMS standards - ISO9001
QMS, ISO13485 QMS and FDA 21 CFR Part 820 is strongly
- 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
- 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
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 firstname.lastname@example.org to request
If you've ever wondered what's within you, there's no better
time to find out.