What are the responsibilities and job description for the Quality Engineer position at Indotronix Avani Group?
Job Title : Quality Engineer II
Location : Tewksbury, MA, 01876
Duration : 12 Months Contract
Description of Work :
- Generates, reviews, and maintains division-level quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiates Change Controls and Document Change Requests to update procedures and processes. Collaborates with manufacturing and distribution sites to assess the impact of changes to site-level processes.
- Acts as a lead auditor for division internal audit program.
- Assists with completing quality projects and uses root cause analysis to assist in completing CAPAs.
Minimum Qualifications :
Skills / Experience :
