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:
- Bachelor's Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred).
- Master's Degree, 1+ years of work equivalent experience (work in a manufacturing environment is preferred).
Skills/Experience:
- Previous experience using ETQ software preferred
- Proficiency in Microsoft office
- ISO 13485 and 21 CFR 820 Quality Management Systems knowledge