Quality Assurance Supervisor
Company: Cepheid
Location: Walnut Grove
Posted on: May 2, 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.At Cepheid, our vision is to be the leading provider of
seamlessly connected diagnostic solutions.The Quality Assurance
Supervisor leads the team responsible for the maintenance of
Quality System documentation as related to Device History Record
(DHR) compliance and ensuring accuracy and traceability of data and
in accordance with the requirements of FDA's Quality System
Regulation (QSR) and ISO 13485(ISO). The role has responsibility
for the team to conduct timely and effective GMP review and release
of product and documentation. This position is part of the Quality
Assurance Team and will be located in Lodi, California.In this
role, you will have the opportunity to:
- Prioritize the daily QA team activities to ensure DHR review
and product release service levels are met.
- Train and supervise QA personnel to support QA review and
release activities.
- Provide guidance on completeness and compliance with QSR and
ISO requirements; ensure good documentation practices are followed.
Address deficiencies and ensure completion of follow-up actions,
specifically those that target process fixes to maintain consistent
resolution to all batch review issues.
- Generate or update written standard operating procedures to
define and improve Quality System functions.
- Develop and maintain QA metrics to track batch record and
document review capabilities and workflow. Maintain and report out
Daily Management KPI and release metrics.The essential requirements
of the job include:
- High School degree with 8+ years of leadership experience,
Bachelor's degree with 5+ years of experience in scientific,
quality system, or related discipline, with minimum 3 years of
quality related experience in a regulated manufacturing environment
or Medical Device experience
- Extensive knowledge of QSR and ISO 13485 requirements
- Significant experience and understanding of quality assurance
processes within the medical device industry with an analytical and
organized approach.The salary range for this role is $90,600 -
$124,600. 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.At 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, Elk Grove , Quality Assurance Supervisor, Other , Walnut Grove, California
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