Validation Quality Technician

Validation Quality Technician

Location:

Acton, Massachusetts

Duration: 6 month contract w/possibility for extension

Role Overview

The Quality Technician is responsible for executing test method validations, process validations, and other engineering studies in accordance with written protocols and procedures. This role collaborates with Quality Engineering to ensure new and existing products conform to the client Quality System, Quality System Regulation, ISO 13485, and ISO 14971. The position involves maintaining quality records in compliance with Good Documentation Practices (GDP) and serving as a quality representative on remediation efforts.

Key Responsibilities

• Follow validation and verification protocols to execute engineering studies, process validation, and test method validation.
• Enter and maintain data in compliance with internal and external quality records requirements, following Good Documentation Practices (GDP).
• Work independently with minimal instruction from a production supervisor, demonstrating attention to detail and organizational skills.
• Collaborate in small groups and cross-functional teams to troubleshoot issues and implement corrective actions.
• Perform other duties as required.

Required Qualifications

• High School Diploma or GED.
• Experience in quality in an FDA-regulated industry.
• Experience performing test method validation and process validation of medical device products.
• Experience with word processing, spreadsheet, and database programs.
• Must be proficient in the English language to read documentation, communicate, and write.

Preferred Qualifications

• Previous experience working in a clean room environment.
• Manufacturing and/or inspection experience in a regulated industry.
• Knowledge of raw materials, measurement instruments, production processes, and quality control for the manufacture or inspection of medical devices.
• Understanding of root cause analysis techniques.
• Experience with ETO sterilization methods.

Work Environment

• Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including Clearly Rateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.