quality engineer

Randstad • Tewksbury, MA

428d • $76,419 - $106,974

About The Position

The Quality Engineer position is crucial for a leading materials science manufacturing company in Tewksbury, MA. This role focuses on maintaining and updating quality management system documentation, leading internal audits, managing change controls, and supporting continuous improvement initiatives while ensuring compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.

Requirements

• Bachelor's Degree and 3+ years of equivalent work experience (preferably in manufacturing).
• Master's Degree and 1+ years of equivalent work experience (preferably in manufacturing).
• Experience using ETQ software (preferred).
• Proficiency in Microsoft Office.
• Knowledge of ISO 13485 and 21 CFR 820 Quality Management Systems.
• Internal auditor experience and/or training.
• Detail-oriented with a focus on accuracy.
• Ability to understand basic mathematical concepts (percentages, ratios, proportions).
• Ability to work across matrix organizations and with external consultants.

Nice To Haves

• Experience using ETQ software (preferred).

Responsibilities

• Generate, review, and maintain division-level quality system documents in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
• Initiate Change Controls and Document Change Requests to update procedures and processes.
• Collaborate with manufacturing and distribution sites to assess the impact of changes to site-level processes.
• Monitor and assess quality system metrics to ensure continued compliance.
• Act as a lead auditor for the division's internal audit program.
• Assist with completing quality projects and use root cause analysis to resolve issues in CAPAs.
• Support or lead continuous improvement initiatives for quality management system processes.
• Assist with regulatory activities related to quality management systems.

Benefits

• Health insurance coverage.
• 401K contribution.
• Incentive and recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree