Headquartered in Tucson, Arizona, we are a provider of instruments and reagents for molecular profiling applications.  Our mission is to empower precision medicine at the local level.  In 2013, we commercialized our Edge instrument platform and a portfolio of RNA assays that leverage HTG’s proprietary nuclease protection chemistry.  Our Edge system capabilities have been expanded to fully automate sample and targeted library preparation for next-generation sequencing.  Additional information about us is available at www.htgmolecular.com.

We have an immediate need for a full time Quality Specialist to join our team.

Essential Duties:

• Responsible for activities involving quality assurance and compliance with applicable regulatory requirements (FDA Quality System Regulations, ISO 13485, etc.)
• Responsible for the maintenance and improvement of key Quality systems and processes as well as insuring those quality requirements are defined and met during design, development and release to manufacturing. The incumbent will work in a multidisciplinary environment requiring a broad range of experience, analytical, communications and interpersonal skills.
• Responsible for implementing and monitoring of new programs, applicable regulatory and statutory requirements, and defining quality requirements for development, production and post-market activities.
• Ensures that quality system requirements and deliverables are met during the design and production/process control processes
• Interface with Development and Manufacturing Operations to ensure that design transfer of new products is in accordance with approved specifications.
• Plays a major role in the maintenance of an ISO 13485 and QSR Compliant Quality Management System, assisting the Quality leadership in establishing, implementing and maintaining the quality management system in line with HTG’s strategic goals.
• Collects Quality System performance metrics for measurement against Quality Objectives
• Review of failure investigation/root cause analysis corrective action(s).
• Monitor and tracking of customer complaints.
• Assist in the root cause analysis and any associated corrective and preventive action(s) in response to customer complaints.
• Works with R & D and outside testing facilities to ensure that new products meet both domestic and appropriately identified international standards.
• Conduct audits, including risk assessments, creating audit finding reports and approval of proper corrective and preventive actions, and closing out audit findings.
• Ensure timely resolution of product quality investigations and associated corrective actions.
• Assist in the preparation of technical files and declarations of conformity to various international directives to support product commercialization.
• Responsible for the design, development, delivery, and evaluation of both traditional classroom and e-learning instruction.
• Facilitates and conducts internal training on quality assurance requirements, processes, and procedures.
• Provides support during FDA and other regulatory body inspections.
• Developing professional expertise, assists in the application of HTG policies and procedures to resolve a variety of quality systems issues.
• Normally receives general work instructions on routine work and detailed instructions on new projects or assignments. 
• Performs evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Identifies compliance risk and evaluates deficiencies while working with internal departments (Operations, Development, etc.) for appropriate remediation.
• Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. 
• Exercises judgment within defined procedures and practices to determine appropriate action.