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.