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.
Bachelor’s degree in a life science or engineering discipline required, some graduate education preferred; in lieu of degree additional years of relevant experience and/or education may be considered.
Minimum of 2 years’ experience in quality systems in an IVD environment, preferably molecular diagnostics.
Knowledge of commonly-used concepts, practices, and procedures for medical device design, development, manufacturing, and post-market support.
Possess an appropriate set of mathematical, statistical and scientific problem-solving knowledge to bring to bear on problems encountered.
ASQ Certified Engineer, Certified Reliability Engineer, certified Biomedical Auditor or Certified Internal Auditor, and strong QA design experience are all desirable.
FDA Quality System Regulations and ISO 13485 is required. In Vitro Diagnostic Medical Device Directive knowledge and experience is desirable.
Excellent communication and interpersonal skills.
Additional Salary Information: bonus potential in addition to salary
About HTG Molecular Diagnostics, Inc.
Empowering precision medicine at the local level – that’s our mission. That means we work with researchers and pharmaceutical companies who are working to identify genetically-specific treatments for cancer patients by providing them instruments, reagents, and services for molecular profiling applications. Molecular profiling is the collection of information about multiple molecular biomarkers, such as DNA and RNA.
At HTG Molecular Diagnostics, Inc. ("HTG"), we are always looking for talented individuals to help us deliver our next-generation sequencing-based products throughout the world. Headquartered in Tucson, AZ, HTG’s technology is being adopted rapidly and we are looking for passionate people to fill our current openings. Are you ready to join the fight against cancer? Our technology and people make all the difference and customers say we are easy to do business with.
Our advantage is simple; deliver high quality molecular profiling products and services that:
Use very small amounts of sample, thus preserving precious tissue or blood samples
Use a simple workflow and deliver results in days not weeks
Are backed by passionate people who drive to make “progress... daily” and “significant progress weekly.”
We offer competitive salaries and a comprehensive benefits program, and the opportunity to advance your professional growth and career aspirations. HTG is making a difference in the fight against cancer. If you want to make an impact today and be part of a high-energy team, apply now!