- 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.
- 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.
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Quality Assurance Supervisor - Galt, United States - Cepheid
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 Danaher Business System 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 FDAs 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:
The essential requirements of the job include:
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 Companys 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 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 to request accommodation.
