Quality Systems Associate
- 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
- 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.