Quality Manager - Potomac Park, United States - Stellar Ventures

Stellar Ventures
Stellar Ventures
Verified Company
Potomac Park, United States

2 weeks ago

Michael Johnson

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Michael Johnson

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Description

Schmitt Engineering is a medium-sized company headquartered in Erlangen.

With many years of engineering expertise in various industries, we are a partner to the industry. Our activities cover the entire process chain from planning and project management to development and design, as well as production, assembly, and commissioning.

Your responsibilities:

  • Independent consulting on the implementation of regulatory, normative, and legal requirements in the context of the product lifecycle process in the field of medical technology (with a focus on software development)
  • Participation in the verification of quality-related artifacts and development results
  • Responsible for the completeness of quality records for the project according to the product development process
  • Support in risk analyses of the product
  • Co-responsible for the conformity of products with the requirements of international target markets and in particular the conformity with the European Medical Devices Regulation (EU) 2017/745

Your profile:

  • Completed studies in the field of medical technology, biomedical engineering, electrical engineering, or a comparable qualification
  • Experience with international quality management systems and in the field of conformity of medical devices (QMS, e.g. ISO 13485, 21 CFR 820, 812, MDD/MDR, as well as ISO 14971 and IEC 623
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