Design Quality Assurance Engineer IV
Charlton, MA, US, 01507
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!
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KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Nearest Major Market: Worcester