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Design Quality Assurance Engineer IV

2 months ago

Charlton, United States KARL STORZ Endoscopy - America Full time

Who we are: 

As a globally independent, family operated MedTech company, we ambitiously think in generations instead of fiscal quarters. At KARL STORZ our 9,000+ global associates pride ourselves on harnessing leading technologies, precise workmanship, and dedicated customer support to support the future of medical technology as we pioneer the way forward. We are setting new standards in precision and safety, from improving diagnosis to enhancing outcomes. We see beyond the limits of traditional medicine. Because it’s not just about the tools we create. It’s about the lives we change. Together, we can do so much  

 

If you are a detail-oriented engineer with a passion for compliance and technology, KARL STORZ wants you to consider our Compliance Engineer (IV) position.

 

In this role, you will oversee component planning with Electronics Engineers globally and play a crucial role in establishing global standards. 

 

You’ll have the opportunity to work on innovative projects, shaping the future of medical technology.

 

In this position, you will be instrumental in solving complex vendor-related component issues; selecting, qualifying, and ensuring compliance for components used in our cutting-edge technology. As a key technical interface between suppliers and development engineers, you will drive improvements in quality, reliability, and cost-effectiveness. 

 

What you’ll be doing: 

  • Lead global initiatives in component selection, research, and documentation to meet quality, manufacturability, and regulatory requirements. 

  • Develop and maintain global guidelines, including preferred parts, derating, and tolerance analysis. 

  • Collaborate with Electronics Engineers on component analysis, cost reduction strategies, and specifications. 

  • Manage component compliance in line with regulations like China RoHS and REACH, coordinating with QA and Material Compliance teams. 

  • Facilitate end-of-life (EOL) projections and manage EOL replacement efforts with cross-functional teams. 

  • Evaluate supplier change notifications, qualify changes, and provide expert support in design reviews. 

  • Act as the Altium schematic and PWB design tool librarian, maintaining the global parts library. 

  • Ensure compliance with global regulatory standards and provide training on component selection and characteristics. 

  • Participate in product development teams to create, manage, and audit design history files and technical documentation through the design control process. 

  • Ensure compliance with FDA/QSR and ISO design control regulations. 

  • Develop standards of best practice to be applied to Flexible Endoscope Development projects and, as applicable, the global Product Development group. 

  • Participate in and lead (as required) global project teams working to ensure continued compliance with national and international standards. 

  • Responsible for participating in the Design Controls portion of all regulatory agency audits which involve Flexible Endoscope Development. 

  • Perform internal audits of Design History Files, technical documentation, and FED procedures and documentation to ensure compliance. 

  • Investigate and respond to corrective actions in a timely manner. 

  • Serve as a point of contact for KARL STORZ Regulatory Departments. 

  • Responsible for understanding the application of relevant standards to the activities of Flexible Endoscope Development, to stay current on new revisions, and to ensure compliance. 

  • Performance of gap analysis for revised applicable standards. 

  • Identify and review new standards to determine applicability to Flexible Endoscope Development instruments. 

 

What you need to be considered for the role: 

  • Bachelor’s degree required – Mechanical, Electrical or Software Engineering preferred and a minimum of 10 years in component engineering. 

  • 8 or more years of experience in a Medical Device design / manufacturing environment working under FDA and/or ISO regulations.  

  • Experience in new product development of reusable medical devices required. 

  • Familiarity with U.S. FDA Quality System Regulation (21 CFR Part 820) and international quality standards (ISO 13485, ISO 9001). 

  • Ability to evaluate electronic component data sheets and their application in specific circuit designs preferred. 

 

Come join a team where your expertise in compliance and engineering will directly contribute to the reliability and success of our products and improve the health of patients globally

 

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