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New Job Opportunity: Design Quality Engineer / Cybersecurity (Full Time)


Responsibilities

Actively execute quality assurance in design development, including but not limited to:

  • Support design control deliverables.

  • Support implementation of eQMS including migration of design inputs, risk documentation and other QMS and product documentation.

  • Author verification and validation protocols and reports.

  • Author test method validation such Gauge R&R and Attribute Agreement Analysis.

  • Drive execution of verification and validation activities.

  • Support writing and approving risk management documentation, such as risk management plans, risk analysis, FMEAs, risk management review/ report, etc.

  • Engage team in weekly activities, to ensure design control activities are being carried out in accordance with the company procedures and applicable regulatory requirements.

  • Ability to work with different small teams and take directions from Sr. Consultant.

  • Support QMS compliance.

  • Support information security/ cybersecurity compliance per ISO 27001.

  • Support medical device software compliance per IEC 62304.

  • Support usability engineering per IEC 62366-1.

  • Ability to travel approximately 10% of the time.

  • Remote work is allowed.


Education, Experience and Background Requirements

  • 5+ years of experience in a product development quality role at a medical device company.

  • Background/education in engineering/science or related field.


Training and Skills Requirements

  • Strong communication skills and experience working in small teams.

  • Experience with FDA 21 CFR Part 820, ISO 13485:2016.

  • Preferred experience with ISO 27001 - Information Security and IEC 62304 - Medical Device Software Compliance.

Apply

  • Send us a copy of your resume to admin@qesmedical.com with the subject “Design Quality Engineer / Cybersecurity (Full Time)”

  • Write a brief description of why you think you are a good fit for this role.

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Responsibilities Actively execute quality assurance in design development, including but not limited to: Support design control deliverables. Author verification and validation protocols and reports.