Overview
Test Method Validation Specialist Jobs in Marlborough, Massachusetts, USA at Mastech Digital
This range is provided by Mastech Digital. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$44.00/hr – $46.00/hr
Job Summary: We are seeking a detail-oriented and knowledgeable Test Method Validation Specialist to assist in reviewing and improving test method validation documentation, ensuring compliance with regulatory standards such as FDA and ISO 13485. This role involves supporting the validation process, implementing remediation plans, and maintaining accurate records of all validation activities. The ideal candidate will have experience in test method validation and a strong understanding of regulatory requirements.
Key Responsibilities:
Test Method Validation Support:
Review and improve existing test method validation documentation.
Implement remediation plans to bring test methods into compliance with current regulatory standards.
Assist in the validation of test methods for raw materials, in-process materials, and finished products.
Documentation and Compliance:
Ensure all validation documents meet FDA, ISO 13485, and other relevant regulatory requirements.
Maintain accurate and organized records of all validation activities.
Ensure proper documentation practices in accordance with industry standards.
Quality Assurance and Testing:
Perform inspections and set quality assurance testing models for analysis of materials.
Assist in the development and review of testing procedures to ensure product quality.
Collaboration and Reporting:
Work closely with supervisors and managers to ensure tasks are completed according to guidelines.
Report validation progress, issues, and findings to the management team.
Qualifications:
Bachelor’s degree in Engineering, Quality Assurance, or a related field.
3-5 years of experience in test method validation or a related area.
Familiarity with FDA, ISO 13485, and other regulatory standards.
Knowledge and Skills:
Knowledge of test method validation concepts, practices, and procedures.
Proficiency in technical writing and creating detailed documentation.
Ability to follow established guidelines and instructions.
Strong attention to detail and organizational skills.
Seniority level
Associate
Employment type
Contract
Job function
Quality Assurance, Engineering, and Other
Industries
Medical Equipment Manufacturing, Manufacturing, and Engineering Services
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Title: Test Method Validation Specialist
Company: Mastech Digital
Location: Marlborough, Massachusetts, USA
Category: Quality Assurance – QA/QC (QA Specialist / Manager, Quality Control / Manager, Quality Technician/ Inspector, Quality Engineering)
