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Medical Device Software Quality Engineer (East Coast USA)

  • Full Time
  • Anywhere

Deciphex

The Medical Device Software Quality Engineer will support software quality for medical device product development, day-to-day Quality Management System (QMS) operations to ISO 13485:2016 and MDSAP requirements, and assist with regulatory compliance activities for medical software primarily in the US and Canadian markets.

Requirements

  • Degree or equivalent in a relevant discipline (e.g. life sciences, engineering, quality management, regulatory affairs) or equivalent experience.
  • Training or coursework in ISO 13485 or quality management systems is desirable.
  • Regulatory affairs training (e.g. RAC coursework) or internal audit training is an advantage.
  • Minimum 3 years of experience in a quality, regulatory, or related role in a medical device, IVD, pharmaceutical, or regulated software environment

Originally posted on Himalayas

To apply for this job please visit himalayas.app.

Working in United States

The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic consisting of 50 states and a federal capital district, Washington, D.C. The 48 contiguous states border Canada to the north and Mexico to the south, with the semi-exclave of Alaska in the northwest and the archipelago of Hawaii in the Pacific Ocean. The United States also asserts sovereignty over five major island territories and various uninhabited islands in Oceania and the Caribbean. It is a megadiverse country, with the world's th

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