Validation Quality Technician

Industry: Pharmaceutical Industry

Job Title: Validation Quality Technician

Location: Acton MA 01720

Duration: 4 months contract

Pay Range: $30-32/hr on W2

The validation quality technician plays a vital role in ensuring the integrity and compliance of medical device manufacturing processes. Responsible for executing test method and process validations, this individual maintains validated states for production activities. Collaborating closely with quality engineering, the technician ensures that both new and existing products meet all quality standards, including industry regulations and applicable ISO standards. A strong focus on maintaining detailed quality records and participating in remediation efforts to uphold compliance is essential.

• Follow validation and verification protocols to execute engineering studies, process validation, test method validation (including Gage R&R and Attribute Agreement Analysis), and process verification studies.
• Enter and maintain data in accordance with quality record requirements, adhering to Good Documentation Practices (GDP).
• Demonstrate excellent attention to detail, strong organizational skills, and the ability to work independently with minimal supervision.
• Collaborate within small teams and cross-functional groups to troubleshoot issues, identify root causes, and implement corrective actions collectively.
• Serve as a quality representative during wide-range remediation efforts to ensure compliance with internal standards and external regulations.
• Perform additional duties as assigned to support quality and validation activities.

• High School Diploma or GED
• Experience in quality assurance within an FDA-regulated industry
• Proven experience with test method validation and process validation of medical device products
• Proficiency with word processing, spreadsheet, and database programs
• Professional proficiency in English (written and spoken)

• Previous experience working in a clean room environment
• Manufacturing and inspection experience in a regulated industry
• Knowledge of raw materials, measurement instruments, production processes, and quality control techniques related to medical device manufacturing
• Familiarity with root cause analysis techniques
• Experience with ETO sterilization methods is a plus
• Ability to generate and accurately maintain detailed records
• Ability to follow up with task owners to ensure completion of open items

This role offers the opportunity to contribute to the quality and safety of innovative medical devices. It provides hands‑on experience in validation processes within a highly regulated environment, fostering professional growth. The technician will work closely with experienced teams and play a key role in maintaining compliance and supporting continuous improvement initiatives in a dynamic, fast‑paced setting.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.