What are the responsibilities and job description for the Quality Engineer position at NOUS Imaging Inc.?
Quality Engineer Job Description
Who you are
You are looking for a quality engineer position in a fast-paced startup, motivated to
provide valuable work, and excited about supporting state-of-the-art medical technology
that will impact the future of medical care.
What you will do
As the Quality Engineer, you will manage and implement the quality management
system (QMS) to ensure high-quality submissions to the FDA in compliance with
regulations and guidelines for software products. You will also be responsible for
Quality Assurance activities for the SaMD product.
● Be the forward face of customer support. Use your technical background to
gather information on-field issues, interact with users, reproduce and solve
customer problems, and act as the liaison between engineers and users.
● Keep up to date on Software as Medical Device (SaMD) and related
regulations and guidance governing product development.
● Support validation of production software.
● Maintain and promote a culture of compliance and a keen focus on quality and
customer requirements.
● Follow-up on Internal and External QMS Audits results.
● Assume primary responsibility for leading cross-functional product quality
planning teams for new launches and changes to existing products.
● Quality review of Software verification and validation activities
● Participate in Design Control Activities for the SaMD
What you will need
● 3 years of experience in Medical Device Quality Operations
● Experience with US and international regulation of software as a medical
device.
● Bachelor's degree (preferably science or engineering discipline)
● Knowledge and experience with implementing QMS processes that meet the
requirements of ISO 13485, 21 CFR 820, and MDR.
● Intermediate to advanced skills in Microsoft Office.
● Experience working in cross-functional teams.
● Excellent communication skills.