Design Quality Assurance Engineer IV

1 month ago

Charlton, United States KARL STORZ Endoscopy - America Full time

Are you a detail-oriented engineer passionate about compliance and technology? Join KARL STORZ as a Compliance Engineer (IV) and play a crucial role in shaping the future of medical technology

 

What you'll be doing:


You will oversee global component planning, establish standards, and solve complex vendor-related issues while ensuring compliance with regulatory requirements.
Collaborate with other Engineering teams to analyze components, reduce costs, and set specifications.
Manage compliance with regulations like China RoHS and REACH, working closely with QA teams.
Facilitate end-of-life (EOL) projections and manage component replacements.
Maintain the global parts library and provide training on compliance standards.
Participate in product development teams to manage Design History Files and ensure adherence to FDA/QSR and ISO regulations.
Conduct internal audits and respond to corrective actions promptly.


 

What you'll need to be considered:


Bachelor’s degree in Mechanical, Electrical, or Software Engineering preferred.
Minimum of 10 years in component engineering, with 8+ years in a medical device environment.
Experience with reusable medical devices and familiarity with FDA Quality System Regulation (21 CFR Part 820) and ISO standards (13485, 9001).
Ability to evaluate electronic component data sheets in circuit designs is a plus.


 

Who we are:

KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike. 

 

With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes. It's not just about the tools we create—it’s about the lives we change, together. 

 

Apply now and be part of a dynamic team at the forefront of medical innovation

 

#LI-BL1

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