Sr. Quality Assurance Specialist

Published date Posted on Indeed on Jan 09, 2022 (13 d ago)

Location – Coralville, IA | Chicago, IL | Remote-US

About Digital Diagnostics:

At Digital Diagnostics, we’re on a mission to transform the quality, accessibility, and affordability of global healthcare through the automation of medical diagnosis and treatment.

Our flagship product – IDx-DR – is an artificial intelligence algorithm where the computer, not the physician, performs the diagnosis. Built on a series of patented machine learning algorithms, our FDA-cleared software platform detects early signs of diabetic retinopathy, a debilitating eye disease that impacts 30+ million people with diabetes in the US.

We are using everything we’ve learned from IDx-DR to expand our AI platform across different therapeutic areas like skin cancer. To deliver on our mission, we need to expand our team of highly skilled and motivated team members to help us change healthcare for the better!

Who We Are:

Working for Digital Diagnostics offers you the opportunity to:

  • Gain experience working with cutting-edge AI software as a medical device marketed in the US and EU with plans to expand into other markets.
  • Work with world-renowned, visionary computer scientists and clinicians who are pushing the limits of artificial intelligence, computer vision, and machine learning in medicine.
  • Tackle complex challenges and projects with the highest levels of quality and execution for audiences that include top technologists, the FDA, and world-leading healthcare providers.
  • Push the accessibility and quality of healthcare to new heights to improve the lives of millions of people.
  • Contribute to a rapidly growing startup that lives by its mission to do “AI the Right Way”.

What We Are Looking For:

Digital Diagnostics is looking for an enthusiastic, results-oriented quality assurance professional who excels at getting things done.

As a Senior Quality Assurance (QA) Specialist, you will report to the Director of QA and be expected to independently manage the quality management system, provide support to staff regarding quality and compliance issues, conduct and/or host audits, and work on multiple, simultaneous projects which require the ability to manage time flexibly and interact with a variety of people. This role collaborates with teams across the organization including Engineering, Product, Customer Success, IT, Sales, and Marketing.

The Senior Quality Assurance Specialist will be accountable for:

  • Acting as the primary contact for their areas of responsibility. As such, the incumbent will have contemporary knowledge of medical device quality management systems, manufacturing processes, cGMPs, and other applicable regulations, standards, and guidelines
  • Managing CAPAs, complaints, and nonconforming product reports and ensuring appropriate documentation is maintained
  • Independently leading and conducting internal audits of the QMS
  • Facilitating root cause analysis on reported product and QMS issues
  • Providing consultation and support to staff with QMS-related questions
  • Supporting staff in the development and revision of operating procedures, work instructions, and templates
  • Assisting with management review preparations and facilitation
  • Hosting and/or participating in regulatory agency, notified body, and other third-party audits
  • Writing, revising, and reviewing QA-owned operating procedures, work instructions, and templates
  • Conducting reviews of policies, SOPs, work instructions, and templates against applicable regulations and requirements
  • Developing and conducting training on QMS topics
  • Participating in continuous improvement projects
  • Managing deliverables under challenging technical and timeline requirements
  • Adapting to challenges, learning quickly, identifying best paths forward, and coordinating execution of solutions

Requirements:

  • Bachelor’s degree in a scientific, technical, or healthcare discipline or equivalent experience
  • A minimum of 5 years experience in the medical device industry with at least 3 years focused on quality. Experience with software products and/or CSV is a plus.
  • At least 3 years of experience conducting medical device internal audits
  • Thorough knowledge of quality assurance and medical device quality systems including regulatory requirements (e.g., 21 CFR 820, ISO 13485, and EU MDD/MDR)
  • Ability and willingness to work independently, learn new things, and take initiative
  • Detail-oriented with the ability to prioritize efficiently and multi-task
  • Appetite for engaging in a fast-moving, growing startup environment

If this sounds like you, then apply to be our next Sr. QA Specialist!

Feeling over or under-qualified but still think we’re cool? Have a specialty that doesn’t quite line up with this posting? We are recruiting at a number of levels for all sorts of specialties: Check out our career page at https://dxs.ai/about/careers/current-openings/

Unfortunately, we are not able to sponsor an immigration case for employment at this time (for example, H-1B or other employment-based immigration cases).


Let us know

Help us maintain the quality of jobs posted on RemoteTechJobs and let us know if:

Loading...
Success
Error on reporting

Related jobs

Thycotic Thycotic |
|
2 d ago

Position SummaryThycotic needs a highly motivated, self-driven, and detail-oriented Test Engineer to partner with developers, product managers, and technical writers in an Agile-based Sprint team environment that is creating and testing software for commercial release. The right.

NTT DATA Services NTT DATA Services |
|
4 d ago

NTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.We are currently seeking a Mid-Level Web Developer / Engineer to join our

kraken kraken |
|
5 d ago

About KrakenOur mission is to accelerate the adoption of cryptocurrency so that you and the rest of the world can achieve financial freedom and inclusion. In our first decade, Kraken has risen to become one of the largest, most successful and respected crypto exchanges on the pla

The Senior Quality Assurance Analyst performs and leads testing of multiple, large, complex, or strategic software development applications using QA testing practices and frameworks. This role provides appropriate and timely status, metrics and communication to stakeholders. As w

Title: Application Support Engineer(Windows Environment) Remote Here's a summary of JD: Experience and proficiency in scripting enterprise application configurations in Powershell and Linux bashAbility to document current and proposed network diagrams effectively at the operation

Technical Scrum Master#LI-remoteWhy We Need You – The MissionReporting to our Director of Engineering Quality, the Technical Scrum Master will be responsible for managing one or more self-organizing, self-managing scrum teams of 5-8 Developers and QA Engineers. They will he

Arrowroot Capital Arrowroot Capital |
Yesterday

Appvance is the inventor, first to market, and industry leader of AI-driven autonomous testing. Every day we disrupt the software testing industry through our patented Appvance IQ (AIQ) unified test platform. We deliver automated testing to the world’s leading brands using

Arrowroot Capital Arrowroot Capital |
Yesterday

Appvance is the inventor, first to market, and industry leader of AI-driven autonomous testing. Every day we disrupt the software testing industry through our patented Appvance IQ (AIQ) unified test platform. We deliver automated testing to the world’s leading brands using

Black Knight is the premier provider of integrated technology, services, data and analytics that lenders and servicers look to first to help successfully manage the entire loan life cycle. Our deep understanding of regulatory and compliance issues complements the knowledge, techn

More jobs by this company

Digital Diagnostics Digital Diagnostics |
12 d ago

Location – Coralville, IA | Chicago, IL | Boston, MA | Austin, TX | Remote-USAbout Digital Diagnostics:At Digital Diagnostics, we’re on a mission to transform the quality, accessibility, and affordability of global healthcare through the automation of medical diagnosi

Digital Diagnostics Digital Diagnostics |
20 d ago

Location – Chicago, IL or Remote-USAbout Digital Diagnostics:At Digital Diagnostics, we’re on a mission to transform the quality, accessibility, and affordability of global healthcare through the automation of medical diagnosis and treatment.Our flagship product &ndas

Digital Diagnostics Digital Diagnostics |
29 d ago

Location – Coralville, IA | Boston, MA | Chicago, IL | Austin, TX | or Remote-USAbout Digital Diagnostics:At Digital Diagnostics, we’re on a mission to transform the quality, accessibility, and affordability of global healthcare through the automation of medical diagn