Compliance Engineer IV at KARL STORZ Endoscopy - America summary:
As a Compliance Engineer IV at KARL STORZ, you will be responsible for overseeing global component planning, establishing compliance standards, and resolving vendor-related issues within the medical technology sector. Your role involves collaborating with engineering teams to analyze components, managing regulatory compliance with guidelines like FDA/QSR and ISO standards, and conducting audits. With a strong focus on quality engineering, you will contribute to the development of innovative medical devices that positively impact patient care.
Are you a detail-oriented engineer passionate about compliance and technology? Join KARL STORZ as a R&D Quality 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 supplier of advanced medical technology. For 80 years, we've pioneered the most groundbreaking innovations in endoscopy, surgical imaging, and OR integration to benefit patients and healthcare providers alike.
Every day, we apply cutting-edge technology, precision engineering, and award-winning customer support to help healthcare facilities manage costs, streamline operations, and deliver exceptional patient outcomes. With facilities across the country and countless opportunities in the field, we attract a diverse and talented staff, motivated by the chance to make a lasting positive impact. At KARL STORZ, it's not just about the tools we create -it's about the lives we change, together.
Apply Today to make an impact in the medical device industry!
Keywords:
compliance engineering, medical technology, quality assurance, FDA regulations, ISO standards, component engineering, medical devices, vendor management, regulatory compliance, end-of-life projections