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