Quality Assurance Specialist

2 weeks ago


Potomac Park, United States Stellar Ventures Full time

Schmitt Engineering, a renowned engineering company, is seeking a seasoned professional to fill the role of Quality Manager.

With a strong focus on medical technology, this position demands expertise in quality management systems, regulatory compliance, and product development processes.

Your Responsibilities:
  • Provide independent consulting on the implementation of regulatory requirements in the product lifecycle process, with a focus on software development in the medical technology field.
  • Participate in the verification of quality-related artifacts and development results, ensuring adherence to industry standards.
  • Ensure the completeness of quality records for projects, following the product development process.
  • Support risk analyses of products, guaranteeing their conformity with international market requirements.
  • Collaborate in ensuring products meet the requirements of international target markets, particularly the European Medical Devices Regulation (EU) 2017/745.
Your Profile:
  • Hold a degree in medical technology, biomedical engineering, electrical engineering, or a comparable field.
  • Experience with international quality management systems, including ISO 13485, 21 CFR 820, 812, MDD/MDR, and ISO 14971.


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