What are the responsibilities and job description for the Validation Quality Technician position at Meet Life Sciences?
Job Summary
We are seeking a Validation Quality Technician to support validation and quality assurance activities within a regulated medical device manufacturing environment. This role is responsible for executing test method validations, process validations, and engineering studies in accordance with approved protocols to ensure products and processes remain in a validated and compliant state. The Quality Technician will work closely with Quality Engineering to support compliance with FDA regulations, ISO 13485, and ISO 14971 throughout product development, design transfer, and the full product lifecycle.
Responsibilities
- Execute test method validations, process validations, and engineering studies (including Gage R&R and attribute agreement analysis) per written protocols.
- Support process verification and remediation activities to ensure compliance with internal and external quality requirements.
- Maintain accurate quality records in accordance with Good Documentation Practices (GDP).
- Collaborate with cross-functional teams to troubleshoot issues and implement corrective actions.
- Enter, manage, and maintain data in quality systems and documentation tools.
- Participate as a Quality representative in validation and remediation initiatives.
- Follow all applicable quality system regulations, including FDA requirements, ISO 13485, and ISO 14971.
- Perform additional duties as assigned.
Qualifications
- High school diploma or GED required.
- Experience in a Quality role within an FDA-regulated industry.
- Hands-on experience with test method validation and process validation in a medical device environment.
- Strong understanding of GDP and quality documentation practices.
- Experience in clean room manufacturing environments preferred.
- Knowledge of manufacturing processes, measurement tools, and quality control concepts is a plus.
- Familiarity with root cause analysis techniques preferred.
- Exposure to EtO sterilization methods is a plus.
- Ability to stand and walk for extended periods during work shifts.