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Validation Quality Technician / Medical Device

Lancesoft INC
locationActon, MA, USA
PublishedPublished: 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.