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Senior Quality Systems and Regulatory Compliance Manager
1 month ago
At Cepheid, our team is dedicated to improving healthcare through fast and accurate diagnostic testing. We're passionate about developing innovative solutions to solve complex health challenges. As a key member of our team, you'll be responsible for managing Quality Systems and Regulatory Compliance processes to ensure seamless delivery of our diagnostic solutions.
The role involves leading and monitoring site audits, quality system inspections, and ensuring continuous compliance with corporate quality policies and regulatory requirements. You'll also be responsible for leading the quality system team, developing quality training programs, and managing CAPA processes.
In this role, you'll have the opportunity to participate in defining annual quality goals and quality plans, leading quality system management reviews, and monitoring quality key performance indicators. You'll also coordinate problem-solving plans and lead cross-functional teams as needed.
The ideal candidate will have a university degree in Life Science or a related field, at least five years of experience in Quality Assurance, preferably in the diagnostics/medical device industry. Excellent written and verbal communication skills are essential, as well as experience with external audits and global environments.
Cepheid offers a comprehensive benefits package, including health care programs, paid time off, and opportunities for career growth and development. If you're a motivated and experienced Quality Assurance professional looking to make a meaningful impact, we encourage you to apply.
