Job Description:

Avails Medical, Inc. is a well-funded medical device start-up, based in Menlo Park, California. Avails eQUANT and eAST platforms are based on a novel bio-sensor for rapid infectious disease detection. As part of our ongoing growth, we have a full-time opening for a Senior Quality Assurance Specialist. The successful candidate will support our growing quality and regulatory team. ESSENTIAL JOB FUNCTIONSRESPONSIBILITIES:Use a collaborative approach to work with contract manufacturers and design partners to ensure compliance with Avails Medical's Quality Management System, ISO 13485 and FDA regulations.Support design control and review and approval of quality system documentation. Guide Avails Team Members in the execution of Change Requests.Work with the R&D teams to ensure that customer requirements, product requirements and design trace matrices are established and maintained in the eQMS throughout the design and development process.Work collaboratively with the R&D teams to prepare and review quality records generated by Avails team membersdesign partners. Verify that records comply with the product design and development plan and are maintained in the eQMS.Lead Quality Meetings with Avails contract manufacturers (instrument, consumable and reagent kits).Support complaint handling and adverse event reporting activities including returned product investigations.Manage Avails Medical Suppliers.Work with team members to ensure that suppliers are qualified per established procedure.Provide QMS employee training, support and follow-up.Collaborate with Team Leads to ensure that employeecontractor training plans and records are maintained and kept up to date.Develop and document quality management system procedures and work instructions.Provide input for the continuous improvement of the Avails Quality Management System.Support internal and supplier audits and external regulatory inspections.Become an expert in the use and maintenance of the eQMS.Lead the NCCAPA documentation and investigation process.Drive implementation of Corrective Action Plan(s).EDUCATION REQUIREMENTS:Bachelor's degree in a related disciplineEXPERIENCE REQUIREMENTS:Minimum of 5 years of experience working as a quality assurance specialist, quality engineer, or similar role in the medical device industry.Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, 21 CFR 803, 806, 812, and IVD labelingUDI requirements.Experience with design control, design change and design transfer and quality operations supporting product launchLead Auditing experience is preferred.REQUIRED SKILLSQUALIFICATIONS:Ability to work independently and always ready to execute more.Strong analytical, problem-solving and technical writing.Experience with cloud-based Quality Management Systems tools.Experience with maintaining a DHFDMR, Medical Device puter literate, and proficiency with Microsoft Office Suite, Dropbox and data base management is a requirement.PERSONAL TRAITS:Problem solverWorks well under pressure, organized and self-motivated.Strong communication and interpersonal skills and ability to work effectively in teams.Reliable with a high attention to dependent and resourceful.Ability to remain motivated.TRAVEL REQUIREMENTS:10% per year to support Supplier Audits