Location: Lodi,CA, USA
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 worlds 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, were working at the pace of change on diagnostic tools that address the worlds biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the Danaher Business System which makes everything possible.
The Supervisor, Quality Assurance 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 Department and will be in Lodi California and will work for the 12 hours night shift. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.
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.
+ Collaborate with cross-functional teams to facilitate OTD or any miscellaneous requests.
+ 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.
+ Develop and maintain QA metrics to track batch record and document review capabilities and workflow. Maintain and report out Daily Management KPI and release metric
The essential requirements of the job include:
+ Bachelors degree in scientific or related discipline, with minimum 5 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.
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Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
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.
Join our winning team today. Together, well accelerate the real-life impact of tomorrows 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.
For more information, visit www.danaher.com .
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.
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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 ...@danaher.com to request accommodation.
Operating Company: Cepheid