Validation Quality Technician / Medical Device
Lancesoft INC
Acton, MA, USA
6/14/2022
Technology
Full Time
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.
