Quality Specialist

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.
  • Relies on instructions and pre-established guidelines to perform the functions of the job.
  • Builds productive working relationships.
  • Escalates issues to supervisor/manager for resolution, as deemed necessary.
  • Assists with various projects as assigned by direct supervisor.
  • Works under immediate supervision with some latitude in the development and implementation of programs, policies and procedures.

Minimum Qualification:

  • 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.
  • Commonly-used concepts, practices, and procedures for medical device design, development, manufacturing, and post-market support.
  • 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.
HTG Molecular Diagnostics, Inc. is an EEO employer - M/F/Vets/Disabled
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