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Senior Quality Manager

3 months ago

Minneapolis, Minnesota, 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

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