Mar 24, 2022

Manager, Quality Assurance

$85,000 - $145,000 yearly
  • Enable Biosciences
  • South San Francisco, California, USA
Full time Quality

Job Description

Full Job Description:

Enable Biosciences is an award-winning UC Berkeley/Stanford spun-out medical device company where we believe in providing affordable and accessible tests to empower timely diagnosis and treatment of difficult diseases. Based in South San Francisco, Enable leverages its patented ultrasensitive ADAP (Antibody Detection by Agglutination-PCR) technology to detect trace quantities of immunological biomarkers at the earliest treatable stage. Enable has been proudly offering its ADAP assays not only in its 10000 sqft CLIA/research lab but also in renowned institutes worldwide. Excellence of our products and service has been published in numerous peer-reviewed journals. Notably, Enable is proudly working with government entities to provide first-of-its-kind COVID19 testing service to support state-wide monitoring of disease prevalence and vaccination in the California.

Enable Biosciences is seeking an experienced full-time Manager, Quality Assurance to join our rapidly growing team. The primary responsibility is to lead the implementation and enhancements of the various components of the Quality Management System (QMS) ensuring adherence to established internal procedures and in compliance with applicable regulatory requirements, with a focus on ISO 13485:2016 and 21 CFR 820 alignment and compliance. This position also leads and supports daily activities within the Quality team. The ideal candidate has an extensive knowledge and experience working in regulated environments specifically ISO 13485:2016 and 21 CFR 820, and has a sufficient knowledge and experience to lead QMS development, and implementation, to ensuring reliable and effective QMS. This position reports to the Chief Technology Officer.

Responsibilities:

  • Lead and support development, implementation and enhancements of the various components of the QMS per ISO 13485:2016 and 21 CFR 820 requirements.
  • Ensure that QMS processes are developed, implemented, maintained and actively monitored for QMS reliability, and effectiveness.
  • Manage the implementation and maintenance of SOPs and other QMS documents.
  • Provide cross functional day to day support to any QMS related requests or issues. Partner in troubleshooting and investigations of QMS issues to ensure comprehensive and timely closure.
  • Interfaces with management on significant matters, often requiring the coordination of activity across the organization.
  • Lead internal and external inspections.
  • Assist in quality assurance related to the clinical operations.
  • Provide on-going job-related support to laboratory team members and other internal stakeholders.
  • Other quality related duties as assigned.

Requirements:

  • Bachelor's degree in a scientific or technical discipline or similar is required.
  • 5+ years of quality management experience preferably within the in vitro diagnostics space and 2+ years of supervisory/management experience.
  • Experience in developing and maintaining QMS under ISO 13485 and 21 CFR 820, GMP.
  • Experience with ISO:13485 audits and FDA inspections.
  • Experience with Greenlight Guru highly desirable.
  • Experience in design control, verification and validation plan development with cross-functional engineering team highly desirable.
  • Experience and knowledge of ISO 14971 Risk Management standard.
  • Ability to critically evaluate and troubleshoot complex problems and attention to detail.
  • Attention to detail, solid execution, meeting aggressive timelines, strong interpersonal skills and team player.
  • Ability to establish operational plans and strategy. Requires a balance of scientific and operational/project management and team leadership expertise.

All candidates are expected to display exceptional communication and professional skills. Competitive pay and benefits (health, dental, commuter, matching 401k contribution, employee equity plan) offered for full-time employees.

This is an in-person position. Vaccination, social distancing, and facial covering protocols are in place to prevent the spread of COVID-19.

Job Type: Full-time

Pay: Up to $145,000.00 per year

COVID-19 considerations:
Masks, hand sanitizer, sick time, vaccination, rapid test kits and PCR testing through Kaiser.


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