Senior Supplier Quality Engineer
Company: Cepheid
Location: Los Gatos
Posted on: May 6, 2024
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 which makes everything
possible.The Senior Supplier Quality Engineer is responsible for
quality engineering and management activities with suppliers
driving quality improvement, ensuring compliance, and supporting
Value Add Value Engineering (VAVE) / Expansion project activities.
The Supplier Quality Engineer will also assist in maturing Supplier
Quality processes and partnering with suppliers to drive proactive
and systematic improvements. -This position is part of the Supplier
Quality Engineering department and will be located in Sunnyvale,
CA, Hybrid, with expectation to work onsite three days per week.
-At Cepheid, our vision is to be the leading provider of seamlessly
connected diagnostic solutions.In this role, you will have the
opportunity to:
- Establish needed quality compliance and proactive initiatives
including supplier process audits and assessments, supplier risk
classifications, supplier corrective action processes, supplier
onboarding, and supplier evaluations. -
- Define, and apply the manufacturing quality toolset including
NCR, SCAR, SRB, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system
analysis, control plans, process verification/validation plans,
validation protocol development, Cpk/PpK, Cp, SPC, incoming
inspection plans, inspection methods, DOE, process data analysis,
and DMAIC/PSP.
- Initiate and collaborate with product support teams,
engineering and others of complex issues on supplier quality
issues, supplier changes, supplier quality agreements, and other
supplier initiatives. This includes to represent and lead Quality
in NPI and Sustaining projects providing quality engineering
services to assigned projects. Ensure defendable engineering and
scientific analyses are employed and DHF/DMR comply with company
policies and governmental regulations.The essential requirements of
the job include:
- Bachelor's degree in Mechanical Engineering, Biomedical
Engineering, Biology/Chemistry, or scientific discipline field with
5+ years of related work experience OR Master's degree with 3+
years of related work experience
- Develop and understand the application of production and
process controls including process validation, process control
plans and statistical process control utilizing best practice and
innovation.
- Utilization and application of Statistical methods for
computing and analyzing data and driving measures and actions for
improvement
- Background in Manufacturing Process and Quality System
improvements working in a Team Environment utilizing best practices
and innovation
- History developing business processes and quality systems
enhancements (product design through manufacturing) in a mature
industry with stringent quality regulations
- Must be able to travel internationally up to 10%It would be a
plus if you also possess previous experience in:
- FDA / GMP 21CFR820
- ISO 13485
- Certified Lead Auditor
- Reagent/Assay and other Material Consumable experienceCepheid,
a Danaher operating 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 .At
Cepheid we believe in designing a better, more sustainable
workforce. We recognize the benefits of flexible, hybrid working
arrangements for eligible roles and are committed to providing
enriching careers, no matter the work arrangement. This position is
eligible for a hybrid work arrangement in which you can work part
of the time at the Company location identified above and part of
the time remotely from your home. Additional information about this
hybrid work arrangement will be provided by your interview team.
Explore the flexibility and challenge that working for Cepheid can
provide.The salary range for this role is $103,000 - 154,533. -This
is the range that we in good faith believe is the range of possible
compensation for this role at the time of this posting. We may
ultimately pay more or less than the posted range. This range may
be modified in the future.This job is also eligible for
bonus/incentive pay.We offer comprehensive package of benefits
including paid time off, medical/dental/vision insurance and 401(k)
to eligible employees.Note: No amount of pay is considered to be
wages or compensation until such amount is earned, vested, and
determinable. The amount and availability of any bonus, commission,
benefits, or any other form of compensation and benefits that are
allocable to a particular employee remains in the Company's sole
discretion unless and until paid and may be modified at the
Company's sole discretion, consistent with the law.#LI-LCSAt
Danaher we bring together science, technology and operational
capabilities to accelerate the real-life impact of tomorrow's
science and technology. We partner with customers across the globe
to help them solve their most complex challenges, architecting
solutions that bring the power of science to life. Our global teams
are pioneering what's next across Life Sciences, Diagnostics,
Biotechnology and beyond. For more information, visit .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 .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.
Keywords: Cepheid, Arden-Arcade , Senior Supplier Quality Engineer, Engineering , Los Gatos, California
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