Validation Quality Technician / Medical Device

Job Description

Job Description

Title: Validation Quality Technician

Location: 100 Nagog Park Acton Massachusetts 01720

Pay Rate: $30/hr on W2

Responsibilities:

• Execute process and test method validations (including Gage R&R and Attribute Agreement Analysis)
• Maintain quality records following Good Documentation Practices (GDP)
• Support engineering studies and process verification
• Collaborate with cross-functional teams to resolve quality issues
• Ensure compliance with FDA regulations, ISO 13485, and internal quality standards

Qualifications:

• High School Diploma or GED
• Experience in Quality within an FDA-regulated industry
• Experience with process/test method validation in medical devices
• Proficient with Microsoft Office (Excel, Word)
• Strong attention to detail and documentation skills
• Cleanroom experience preferred
• ETO sterilization experience is a plus.

Physical Requirements:

• Ability to stand for extended periods and walk throughout the shift.