Quality Assurance Supervisor (Night Shift) in Lodi, California 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.
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 in accordance with the requirements of FDA's Quality System Regulation (QSR) and ISO 13485. 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, working the 12-hour night shift.
In this role, you will have the opportunity to:
Prioritize 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.
Develop and maintain QA metrics to track batch record and document review capabilities and workflow.
The essential requirements of the job include:
Bachelor's 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.
Cepheid offers a broad array of comprehensive, competitive benefit programs that add value to our lives. The salary range for this role is $90,600-124,600, and this job is also eligible for bonus/incentive pay.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology.
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