We’re looking for an experienced Director of Quality Assurance and Regulatory Affairs to join our team of high-performing entrepreneurs and professionals to ensure all necessary compliance of our tests and instruments both under development and in the future. The Director of QA/RA, reporting directly to the Chief Operations Officer, works in conjunction with executive management and company leadership to develop strategic and tactical plans to ensure compliance with national and international quality management system requirements. This individual has the overall responsibility for maintenance and continuous monitoring and improvement of the company's Quality Management System, in conformance with ISO standards, FDA's QSR/GMP requirements, and any other applicable regional in-vitro diagnostic (IVD) regulations.
- Lead and develop the Quality Assurance team
- Further develop and implement UOL’s Quality Strategic Plan for diagnostic medical devices.
- Initiate and maintain ISO-13485 registration.
- Ensure on-going compliance with FDA's QSR/GMP requirements and any other applicable regional in vitro diagnostic regulations
- Serve as the primary point of contact with the Company's notified body/external auditor
- Drive continuous monitoring and process improvements.
- Partner with cross-functional leadership to ensure all aspects of Product Development and Delivery are performed in conformance to the quality management system and regulatory requirements.
- Improve customer satisfaction through Quality initiatives and process improvement.
- Help team members generate required documentation; maintain document control
- Train company employees on compliance with quality system standards
- Participate with the management team in developing and implementing relevant business and strategic plans.
- Plan, coordinate and direct quality strategies for new products.
- Manage quality control, quality assurance, supplier quality, calibration, complaint handling and document control
- Direct investigations and implement corrective actions to resolve complaints and non-compliance instances.
- Develop and implement quality system management strategies and plans to include resources, systems, timelines and financials that support, contribute to and integrate with the company's annual and long term strategy.
- Manage all certifications and product approvals (i.e. MDSAP, ISO9001, etc.)
Required Skills and Qualifications:
- Undergraduate or advanced degree (B.S., M.S., or Ph.D.) in a Life Science, Physical Science, Engineering, or a similarly technical field
- A minimum of seven (7) years of experience implementing and/or maintaining quality management systems in an FDA GMP or ISO-13485 regulated industry setting.
- At least three (3) years of management experience in a medical device company or in-vitro diagnostics company with both domestic and international products.
- In-depth knowledge of and experience with ISO-13485, ISO 14971, GMP/GLP, QSR, 21 CFR 820. 30, and other IVD regulations.
- Experience building and leading high performing teams,
- Proven ability to lead cross-functional teams in problem-solving and continuous process improvement.
- Experience with Quality Management systems and processes
- Deep understanding of regulatory requirements and processes
Preferred Skills and Qualifications:
- Advanced degree (M.S., or Ph.D.) in a Life Science, Physical Science, Engineering, or a similarly technical field.
- A minimum of ten (10) years of experience implementing and/or maintaining quality management systems in an FDA GMP or ISO-13485 regulated industry setting.
- At least five (5) years of management experience in a medical device company or in-vitro diagnostics company with both domestic and international products.
- Experience in a startup environment
- Experience with IVD software, hardware and reagent development
- Experience with Greenlight Guru as an electronic QMS.
Uh-Oh Labs’ headquarters is in Santa Clara, CA. This is a non-remote position, however for the duration of the COVID-19 pandemic, this role has a flexible work from home policy for safety and convenience. All in-person work will be conducted following the most rigorous and up-to-date public health guidelines. The candidate will also be expected to travel to events and meetings as requested by management.