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Quality Systems Manager at Nextern - ApplyBlast

Quality Systems Manager

Nextern

9 days ago

4.0 on Glassdoor

Maple Grove, Minnesota, United States

Onsite

Full Time

Manager

0 applicants

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About this role

The Quality Systems Manager at NPX Medical is responsible for deploying, aligning, and standardizing the Quality Management System and leading the Quality Systems Team. This role involves managing relationships with notified bodies, overseeing audits and certifications, and ensuring product quality meets regulatory standards. The position requires coordinating with global leadership to prioritize initiatives and maintain compliance with ISO 13485 and FDA GMP regulations.

Responsibilities

Directly manage relationships with ISO notified body and regulatory agencies
Lead compliance initiatives and standardize quality metrics across departments
Oversee quality systems team and ensure product conformity to standards

Skills

Qualifications

Bachelor's degree in a STEM related field

About Nextern

nextern.com

Headquarters

Maple Grove, Minnesota, United States

Company Size

501-1000 employees

Founded

2000

View Profile

Nextern is a vertically integrated medical device company that partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. The company offers four core capabilities: product development, manufacturing, precision technologies (including nitinol and advanced catheters), and consulting services covering regulatory, clinical, and quality needs. Nextern operates across five global sites and serves clinical markets including peripheral vascular, interventional cardiology, neuromodulation, electrophysiology, and structural heart.