Quality assurance Consultant

5 days ago

Bedford, NH, United States RIT Solutions, Inc. Full time
Quality assurance Consultant
6-12 months +
2 days onsite in Bedford, NH
5 openings

Position Overview:
Sunrise is looking for a versatile individual with deep skills and experience in medical device development to participate in product development, product verification and perform compliance activities.

Key Responsibilities:
  • Execute testing of electrical, mechanical, and software components and systems as applicable.
  • Follow test protocols; execute testing; complete verification and validation activities
  • Assist in identifying, recommending, implementing, managing, and administering process and software validation.
  • Participate in internal and external audits.
We're Looking For:
  • 3+ years' experience in Quality assurance including medical device design controls.
  • Knowledge of ISO 13485, and global quality assurance requirements for medical devices, including IEC 60601-1
  • Solid understanding of IEC 62304 Medical Software Development Process
  • Familiarity with Risk Management standards ISO 14971
  • Excellent analytical and decision-making skills, as well as strong written and verbal communication
  • Ability to speak effectively before groups of clients or employees.
  • Experience using a variety of software development methodologies (Waterfall, Phase Gate, Agile, SCRUM, Kanban, etc.) is a plus.
  • Experience in modern test automation is a plus.

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