We have an immediate need for a full-time Quality Specialist to join our team.
- 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 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.
Nestled at the foothills of the majestic Catalina Mountains, and ringed by 4 other mountain ranges, a young and family-friendly modern metropolis, Tucson offers 276 days of sunshine, unparalleled golf, museums, historic sites and hiking trails where one can experience the wide variety of animal and plant life of the Sonoran Desert, one of the most biodiverse spots on the planet.
HTG offers competitive salaries and an attractive benefits package including 100% employer-paid medical and dental benefits, long term disability and life insurance, an employee stock purchase plan, and the unique ability to work with cutting edge technological advances.
HTG is an Equal Opportunity Employer
Please apply here