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 late-stage products, HostDx-Sepsis and HostDx-Fever, 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: Senior Quality Engineer
Our Senior Quality Engineer will drive quality, safety, and compliance while working with our project teams through the Product Development lifecycle process to deliver exceptional product. This important position will have direct influence on component, assembly, and final product quality for R&D and production builds. The role also supports 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.
- Represent the Quality department in product design projects
- Review product lifecycle documentation for compliance to regulations
- Oversight over supplier management activities such as qualification, problem solving, support engineering
- Write Quality System process procedures required for regulatory certification and product approvals
- Support project teams to establish related specifications, protocols and reports for development, manufacturing and inspection and test
- Establish quality system metrics and processes in support of management reviews
- 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/strategic thinking to projects and assignments
- Demonstrated ability to work collaboratively with all internal and external partners and stakeholders
- 7+ years of experience in the in-vitro diagnostics (IVD), medical device or the biotech industry
KNOWLEDGE, SKILLS, AND ABILITIES:
- B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience.
- Ability to travel up to 15% 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: firstname.lastname@example.org