Leveraging broad platform technologies developed for planetary protection at NASA, our vision at Verrix is to quantify, contain, and manage the health risks of microbial contamination with the fastest, and most advanced sterility assurance products for hospitals, patients, and healthcare providers.
Verrix, is a private, development stage company pioneering rapid sterilization verification solutions for the hospital environment. Utilizing Endospore Viability Assay (EVA) technology under exclusive license from Caltech, Verrix is developing an EVA system that includes an Ultrafast Biological Indicator (UBI) and a UBI reader capable of microscopic imaging. This technology is expected to reduce validation of the sterilization procedure to 15 minutes from the current competitive offerings of 1-3 hours. Verrix was founded in 2013 and is expanding, with key additions to its management team.
Reporting the CEO, this position plans and directs all activities related to development, application, and maintenance of the company’s Quality Systems and compliance with regulatory requirements for all Verrix product lines and processes. The position is responsible for all Regulatory submissions to the US and foreign governments to allow marketing of the products in all countries and maintaining all compliance requirements for foreign governments. The position is a combined direct contributor and supervisory role responsible for the following areas: inspection, quality engineering, document control, complaint investigation, regulatory affairs and oversees the compliance related to Service Department.
Primary Responsibilities (include, but are not limited to):
Acts as company’s designated Management Representative for ISO and Quality Systems.
- Manages the Company’s Quality System to maintain certification to ISO13485, 21CFR820, all foreign standards, and is current with industry trends and requirements.
- Updates and maintains accuracy of company’s Quality Manual.
- Manages or oversees the relationship with and all communications with ISO registrar and FDA.
- Responsible for the administration and compliance of all quality systems such as: CAPA, Customer Complaint Systems, Training, Product Release and compliance with documented procedures.
- Responsible for developing and approving the Internal Audit schedule, training of auditors, and assuring timely completion of audits.
- Manages Document Control Center and Quality Inspection Lab.
- Oversees external monitoring service and compliance with proper operating conditions of Controlled Environment Spaces, including the validity of all sterilization processes and suppliers.
- Develops and initiates standards and methods for inspection, testing, and evaluation, including all aspects of the product development.
- Interacts with customers, vendors and other employees concerning problems with quality and assures that effective corrective action is implemented.
- Schedules Management Reviews as required and reports to management on quality issues and trends on an ongoing basis.
- Ensures product quality. This will include the reliability and performance of all products.
- Designs, documents and implements methods for process control, process improvement, testing and inspection.
- Responsible for leading the company’s Risk Management compliance.
- Interfaces with other Departments and Human Resources to develop and implement training programs as required.
- Manages the staff to support all quality and regulatory initiatives.
- Manages all department budgets.