ABOUT AVAILS:

Avails Medical, Inc., is a well-funded medical device start-up based in Menlo Park, California. We are a leader in the development of rapid, automated and fully electrical antibiotic susceptibility testing (AST) technologies with our products eQUANT™ and eAST™ platforms based on a novel bio-sensor for rapid infectious disease detection. In 2024, we have announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for our groundbreaking eQUANT™ system. The eQUANT™ system is a leap forward in combating antibiotic resistance, providing a standardized inoculum (0.5 McFarland equivalent) directly from positive blood cultures.

We are dedicated in our drive to make rapid AST accessible and affordable to hospital microbiology labs, empowering them to provide actionable infectious disease treatment information with simplified laboratory workflows to save lives, reduce outcome costs and reduce the threat of global antimicrobial resistance.

As part of our ongoing growth, we have a brand new full-time opening for a Senior Quality Assurance Specialist.

PRIMARY OBJECTIVES:

The senior quality assurance specialist will play an instrumental role in supporting our first product launch. The successful candidate will set up and lead the post market surveillance process for the initial launch of the eQUANT™ system. The role will be a key contributor to the Avails Medical quality and regulatory team and will have the opportunity to shape and organize the post market surveillance program. They will further liaise with the customer support and technical support groups in Menlo Park for complaint handling and other matters.

ESSENTIAL JOB FUNCTIONS / RESPONSIBILITIES:

Lead complaint handling and adverse event reporting activities including returned product investigations.
Become an expert in the use and maintenance of the eQMS system for post market surveillance activities
Drive risk management activities related to post market surveillance
Facilitate implementation of Changes and Corrective Actions from post market investigations
Support external regulatory inspections
Support management review and monitoring of post market surveillance process
Guide Avails Team Members in the execution of post market driven design updates
Collaborate with the R&D teams to ensure that post market surveillance is an input to the design and development process
Work with Avails contract manufacturers (instrument, consumable and reagent kits) to support complaint handling and adverse event reporting activities including returned product investigations

REQUIRED EXPERIENCE & EDUCATION:

Bachelor, Masters, or equivalent relevant experience, in Biological Sciences, Laboratory Sciences or other related fields.
Minimum of 2 years of experience working in post market surveillance, complaint handling or adverse event reporting, in quality assurance, or similar role in the IVD or medical device industry
Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, 21 CFR 803, 806, 812 and IVDR

PERSONAL TRAITS:

Project management skills
Reliable with high attention to detail
Independent and resourceful
Works well under pressure
Organized, and self-motivated

Avails Medical, Inc. jobs

Senior Quality Assurance Specialist