Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Quality Remediation Contractor
  • Assigned for critical tasks in a regulated manufacturing environment, including rework qualification, document updates, CAPA support, risk assessments, and compliance enhancements per FDA, ISO 13485, and GMP standards.
  1. Evaluate and qualify product and process reworks
  2. Review and revise controlled documents
  3. Support impact assessments and risk analysis
  4. Ensure changes are documented appropriately
  5. Collaborate with cross-functional teams.
  6. Participate in root cause investigations, CAPAs, when necessary.
  7. Maintain accurate records

Qualifications:

• Bachelor’s degree in Engineering or related field (or equivalent experience).
• Minimum of 2 years of experience in quality assurance or quality systems within a regulated industry (e.g., medical devices, pharmaceuticals, biotech).
• Strong understanding of GMP, FDA regulations, and ISO.
• Experience with rework validation, document change management, and risk-based decision-making.
• Proficient in using electronic quality management systems (eQMS) and document control tools.
• Languages: Proficient in Spanish and English
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.