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Director of Quality Assurance - IVD/Medical Device/CLIA Lab

Company: Bluestar Genomics, Inc - Early Cancer Detection Co
Location: San Diego
Posted on: January 16, 2022

Job Description:

Reporting to the Chief Medical Officer, you will direct and manage Bluestar Genomics' QA team and systems. Your main responsibilities will include establishing and maintaining a quality system that meets the needs of the company including overall company compliance policies, medical device regulatory requirements of the US FDA, and ensuring coherence with our existing clinical laboratory quality system based on CLIA and CAP guidance.
Responsible for the establishment and maintenance of a quality system that meets the business needs of the company and medical device regulatory requirements of the US FDA
Understand international requirements as applicable to IVD products that the company may develop and distribute as well as clinical regulatory guidance for international collaborations
Facilitate the conduct and documentation of periodic Management Reviews
Coordinate with clinical laboratory QA to ensure that quality system functions are appropriate for LDT/CLIA/CAP regulatory environment: Document control, complaint handling, internal audits, CAPA systems, and training systems
Provide quality support for Design Control projects
Interact with external regulatory consultants on the coordination between quality and regulatory for new design projects including what types of analytical and clinical studies and associated data are needed for FDA regulatory submissions
Facilitate the set up and generation of design control and risk management documents for the Design History File (DHF) and risk management file
Provide guidance in software development lifecycle policies and regulations
Lead and manage the QA team
Collaborate across the company to ensure clinical and FDA compliance is achieved
Exemplify our core values - Visionary, pioneering, truth seeking, driven, honest and considerate communication, embrace diversity and operate with transparency and integrity.

BS degree or equivalent with 10+ years related experience at an IVD or medical device company or CLIA lab with FDA cleared/approved LDT assays
Excellent interpersonal, teaming, written and spoken communication skills.
Strong working knowledge of US regulations including but not limited to 21 CFR 820
Experience in setting up and maintaining a medical device quality system.
Experience in building and leading a team


Come join us in addressing large healthcare needs through precision epigenomic medicine!

Bluestar Genomics is an exciting life science company that is reinventing non-invasive molecular diagnostic testing using next generation epigenomic technologies. We are passionate and dedicated to improving healthcare that will make a significant difference in cancer and other epigenomic-driven diseases. Our technologies provide novel insight and quantitation of human health and disease, with our focus on precision medicine applications improving both clinical and health system outcomes. Our company was founded based on pioneering work in the Stanford laboratory of Stephen Quake, with advisors from Stanford and UCSF.

We look for extraordinary lifelong learners with a passion and growth mindset for these areas, and for combining biological ingenuity with AI and data analysis. Led by a team with decades of experience bringing products from concept to market, we are an equal opportunity employer and value diversity at our company.

We provide generous benefits to all employees including stock options. We are building a world-class company, based in San Diego and San Mateo.

Keywords: Bluestar Genomics, Inc - Early Cancer Detection Co, San Diego , Director of Quality Assurance - IVD/Medical Device/CLIA Lab, Executive , San Diego, California

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