Test Validation Quality Technician

Test Validation Quality Technician (Contract)

Location: Acton, MA (Onsite)

Pay: $30.00/hour

We are seeking a detail-oriented Test Validation Quality Technician to support quality assurance, process validation, and test method validation activities within a regulated medical device manufacturing environment. This contract position is ideal for candidates with experience in quality systems, FDA-regulated industries, validation testing, and manufacturing quality support.

Key Responsibilities

• Execute test method validations, including Gage R&R and Attribute Agreement Analysis studies.
• Perform process validation, process verification, and engineering studies following approved protocols and procedures.
• Maintain accurate quality records and documentation in compliance with Good Documentation Practices (GDP).
• Support compliance with FDA regulations, ISO 13485, ISO 14971, and internal quality standards.
• Collaborate with Quality Engineering and cross-functional teams to investigate issues, identify root causes, and implement corrective actions.
• Participate in quality improvement and remediation initiatives.
• Track validation activities and follow up on open action items to ensure timely completion.

Qualifications

• High School Diploma or GED required.
• Experience in Quality, Manufacturing, or Validation within an FDA-regulated industry.
• Experience performing test method validation and process validation for medical device products.
• Strong computer skills, including Microsoft Word, Excel, and database applications.
• Excellent attention to detail, organization, and documentation skills.
• Ability to work independently and within cross-functional teams.

Preferred Qualifications

• Medical device manufacturing experience.
• Cleanroom experience.
• Knowledge of quality control methods, inspection processes, and measurement equipment.
• Experience with root cause analysis and corrective actions.
• Familiarity with ETO sterilization processes.

Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plan
• Health Savings Account (HSA)
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• AD&D Insurance
• People Perks Program

Ready to build your career in medical device quality and validation? Click Apply Now.

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

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