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Senior Quality Manager

4 months ago

Minneapolis, United States Lumicity Full time

Senior Quality Manager Opportunity with a Medical Device Company As the Senior Quality Manager, you will be responsible for maintaining quality standards, leading the majority of quality efforts, and driving continuous improvement initiatives. You will lead a team of 11 in developing and implementing the Quality Management System. Major Responsibilities: Responsible for Quality System improvements and oversee ISO compliance and FDA regulations Maintain QMS system & procedures Manage overall post market surveillance (PMS) activities to ensure compliance with FDA Collaborate with cross-functional teams including, Manufacturing, R&D, Operations, and Regulatory Affairs Additional duties as assigned **Qualifications:** Bachelor's degree in engineering or sciences. Master's degree preferred 6+ years of experience in Quality with 2+ years as a manager In-depth knowledge of FDA regulations (21 CFR Part 820) and ISO standards (ISO 13485) Strong leadership and communication abilities Compensation: $125k - $175k Hybrid: 3 days on-site, 2 days remote Apply Directly or email thomas.mcmichael@lumicity.io

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