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Engineer II, Quality Complaint Management at Axogen - ApplyBlast

Engineer II, Quality Complaint Management

Axogen

1 month ago

3.2 on Glassdoor

Tampa, Florida, United States

Onsite

Full Time

Medior

0 applicants

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About this role

The Engineer II, Quality Complaint Management at Axogen is responsible for managing the complaint system, serving as the principal complaint investigator, and ensuring compliance with regulatory standards. The role involves drafting health hazard assessments, coordinating adverse event determinations, and supporting interactions with FDA and other regulatory bodies.

Responsibilities

Investigate and manage product complaints across all lines
Prepare and submit regulatory reports such as HHEAs, FARs, and MDRs
Monitor and report complaint system performance and drive continuous improvement

Skills

Qualifications

Bachelor's degree in scientific or medical discipline

About Axogen

axogeninc.com

Headquarters

Alachua, Florida, United States

Company Size

201-500 employees

Founded

2002

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Axogen is a medical technology company focused on advancing peripheral nerve repair, describing its mission as "revolutionizing the science of nerve repair." With more than a decade of experience, it offers a comprehensive portfolio of surgical solutions used primarily by hand, reconstructive plastic, and oral/maxillofacial surgeons to treat a wide range of nerve injuries and help restore sensation and function. The company pairs biologic and engineered products with clinical education and surgeon support to improve patient outcomes and recovery.