Software Compliance and Document Control Specialist

IDx LLC

Coralville, IA Technology / Engineering
About IDx:
At IDx, we believe that automation has the potential to transform the quality, accessibility, and affordability of medical diagnosis. IDx is expanding its team supporting the development of autonomous artificial intelligence (AI) diagnostic systems (medical devices) cleared by the FDA.
As a growing company, every member of our team plays a fundamental role in our success and IDx employees share in the returns of the success they help drive.  IDx offers a fair salary and benefits package, augmented with an equity stake in the company.  We are a private company with substantial funding and a deep product pipeline. 

Responsibilities:
  • Work with IDx software engineering teams to ensure compliance with applicable medical device regulations, standards, and requirements throughout the product lifecycle
  • Oversee the completion, review, maintenance, and archival of engineering documentation including requirements documents, design documents, review meeting minutes, change requests, and other records
  • Monitor SDLC processes to ensure quality objectives and documentation requirements have been met
  • Develop and revise standard operating procedures, work instructions, and templates
  • Collaborate and effectively communicate across departments to ensure project success
  • Contribute to the improvement of software development processes and procedures
  • Support CAPA, complaint, non-conformance, audit and other QMS efforts

Requirements:
  • 3+ years’ experience working with software engineering teams to ensure quality in a highly regulated environment
  • Experience with relevant US and international medical device regulations and standards, quality management system requirements, and/or auditing
  • Excellent written and verbal communication skills
  • Applicants must not now or in the future need IDx to sponsor an immigration case for employment (for example, H-1B or other employment-based immigration cases)
 
What will help you in this role:
  • Exceptional analytical and organizational skills
  • Ability to derive joy from navigating policies, procedures, and regulatory frameworks
  • Obsessive attention to detail
  • Genuine commitment to team work in a fast-paced, entrepreneurial environment
  • Self-starter with a strong initiative to get things done
  • Desire to own decisions and take responsibility for outcomes

The rigors and challenges of work at IDx are not for everyone, but the team has some amazing opportunities to:
  • Work with world-renowned doctors who are pushing the limits of machine learning in medicine
  • Build upon research and distribution partnerships with IBM’s Watson Health team to revolutionize health tech
  • Tackle complex problems/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
 
How to apply:
If you’re interested in learning more about working at IDx, check out eyediagnosis.net/careers
And if you’re ready to help our team build the future of healthcare, send us your resume via email by clicking apply now! 
Applying for:

Software Compliance and Document Control Specialist

IDx LLC

(.DOC, .DOCX, .PDF, .RTF, .TXT, .ODT, .PAGES, .WPS up to 2MB)

Job ID: 69660

Posted 21 days ago

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