Quality Assurance Manager

IDx Technologies LLC.

Chicago, IL / Coralville, IA Technology / Executive & Management

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 after its first product, IDx-DR, became the first ever autonomous artificial intelligence (AI) diagnostic system 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.


Our Ideal Candidate:

Reporting to the Quality Assurance Director, you will bring a minimum of 5-7 years of work experience in quality assurance. You will have an in-depth understanding of QMS requirements, experience conducting a full range of audits, and the ability to interpret and apply regulations and compliance concepts. You will understand that collaborative, cross-functional teams are the most effective and your communication skills will successfully bring diverse groups together.


Key Responsibilities:

  • Partner with IDx staff to ensure company-wide compliance to applicable regulations and requirements, including 21 CFR
  • 820, ISO 13485, ICH GCP, and MEDDEV guidelines
  • Conduct risk-based, routine and complex audits of IDx operations, studies, projects, and systems
  • Host and/or participate in regulatory agency, notified body, and other third party audits
  • Develop, implement, and maintain standard operating procedures, work instructions, templates, and processes as needed
  • Assist in the maintenance of the CAPA program, including tracking status of open actions, receiving and reviewing responses, and working with departments for timely completion
  • Manage and monitor complaint and nonconforming product records
  • Facilitate problem-solving activities with focus on nonconformance and complaint investigations using root cause analysis tools (e.g., flow charts, 5 Whys, Ishikawa diagrams, FMEA)
  • Develop and conduct training for new and existing staff on key quality areas (e.g., FDA and EU regulations, ISO standards, ICH GCP, SOPs, CAPAs, process improvement, problem solving, and best practices)
  • Leads and/or participate in continuous improvement initiatives intended to improve quality


Skills and Competencies:

  • Good working knowledge of industry regulations and their applicability to the work performed by IDx
  • Established communication skills – ability to manage situations, negotiate conflict, and influence others to achieve objectives
  • Significant experience hosting and conducting audits within the medical device industry
  • Experience writing policies and procedures
  •  Process improvement skills
  •  Ability to manage priorities
  • Thrives in a highly dynamic and small company environment
  • Genuine commitment to team work in a fast-paced environment


Requirements:

  • Bachelor’s or master’s degree in life sciences or related discipline
  • 5+ years quality assurance and/or auditing experience in the medical device or pharmaceutical industry
  • Demonstrated experience working under applicable regulations and requirements, e.g., 21 CFR 820, ISO 13485, ICH GCP, and MEDDEV guidelines
  • 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.


The rigors and challenges of work at IDx are not for everyone, but the team here has some amazing opportunities to:

  • Work with world-renowned doctors who are pushing the limits of machine learning in medicine.
  • Build upon and contribute to products that will revolutionize health tech.
  • Tackle complex problems and projects that will establish precedent for autonomous AI in medicine
  • Push the accessibility and quality of healthcare to new heights to improve the lives of millions of people.

Application Instructions:

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 and cover letter by clicking apply now today.


Applying for:

Quality Assurance Manager

IDx Technologies LLC.

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Job ID: 70529

Posted 5 days ago

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