ABOUT THE COMPANY:

Inflammatix, Inc. is a venture-backed diagnostics company bringing the power of precision medicine to the point of care.  We are building novel diagnostic, prognostic, and predictive HostDx™ tests that combine rapid detection of host mRNA panels with advanced machine learning and computational biology.  These tests will be performed on our rapid point-of-care platform instrument currently under development, intended for both US FDA and CE Mark clearance.  Our products, the HostDx-Sepsis and HostDx-Fever systems focus on enabling physicians to better diagnose acute infections and sepsis. Inflammatix is further developing a pipeline of groundbreaking tests that take advantage of our expertise in reading the immune system.

JOB DESCRIPTION: Quality Engineer

Our Quality Engineer will drive quality, safety, and compliance while working with our project teams to deliver an exceptional product. This role will also support the implementation of Inflammatix’s Global Electronic Quality Management System and related training processes to enable regulatory approvals related to Quality System certification and product approval through the FDA, EU, and other regulatory authorities.  We seek an individual compelled to join our dedicated team to bring breakthrough medical technologies to market that can favorably impact patient lives across the globe.

 PRIMARY RESPONSIBILITIES:

  • Represent the Quality department in software product design projects and on product development core teams as assigned
  • Review Design History File documents and Quality System records for compliance with applicable regulatory and retention requirements
  • Write Quality System process procedures, work instructions, and forms as assigned to further develop the Quality System
  • Participate in the validation and implementation of an electronic Quality Management system
  • Lead training compliance assessments, gap reporting, and gap closure
  • Analyze data, report trends, and develop and issue reports in support of management reviews
  • Provide support during internal and external audits as required

 QUALIFICATIONS:

  • Expertise in FDA and EU quality system and product development regulations
  • Working knowledge of the following regulations: 21 CFR 820, ISO 13485, ISO 14971, IVDD/R, IEC 61010-2-101, IEC 62366-1 requirements
  • Ability to apply critical thinking to projects and assignments
  • Demonstrated ability to work collaboratively with all internal and external partners and stakeholders
  • 5+ years of experience in the in-vitro diagnostics (IVD), medical device or the biotech industry, including software quality assurance experience
  • Experience implementing, validating, maintaining, and integrating electronic systems in a start-up medical device or pharmaceutical company preferred

 KNOWLEDGE, SKILLS, AND ABILITIES:

  • B.S. in Biomedical, Electrical, Mechanical, or Systems Engineering or equivalent relevant work experience.
  • Ability to travel up to 10% of the time

SALARY AND CLASSIFICATION:

  • Classification: Full-time
  • Compensation: Competitive and commensurate with experience; includes equity package
  • Benefits: Medical, dental, and vision; 401(k), generous leave and more

HOW TO APPLY:  Please forward a cover letter and resume to:  jobs@inflammatix.com