Quality Systems Associate

Position Responsibilities

  • Provide hands-on assistance for the various elements of the quality system including corrective action, validations, customer complaints, and internal audits to ensure successful performance during third party audits
  • Actively assist with the implementation, maintenance, and improvement of quality systems based on established direction and priorities
  • Ensure efficient and effective processes and tools are established for compliance with QSR requirements and continually improved
  • Provide support to internal functions in the application, maintenance and improvement of quality systems and department specific processes

Position Requirements

  • Bachelor diploma in science, chemistry, medical technology, regulatory affairs, or equivalent combination of education required
  • 1-3 years experience in a medical device environment preferred
  • Demonstrated working knowledge of quality systems requirements and process ownership

Qualifications – Skills

  • Experience with ISO 13485:2003, 14971, and FDA, QSR.
  • Excellent interpersonal skills with all levels of employees
  • Project and personnel management skills

If interested, please send your resume to stephen [at] tecodiagnostics.com.