Quality Remediation Contractor- North PR region

Seeking (8) experienced Quality Remediation Contractors to support critical remediation activities within a regulated manufacturing environment. Contractors will be responsible for assessing and executing quality remediation tasks including but not limited to rework qualification, document revision, CAPA support, risk assessments, and compliance improvements in alignment with applicable regulatory standards (e.g., FDA, ISO 13485, GMP).

Key Responsibilities :

• Evaluate and qualify product and process reworks in accordance with approved protocols and regulatory requirements.
• Review and revise controlled documents (e.g., SOPs, work instructions, protocols, batch records) as part of remediation efforts.
• Support impact assessments and risk analysis for non conformances and historical deviations.
• Ensure changes are documented appropriately with traceability and justification aligned to quality standards.
• Collaborate with cross-functional teams (Engineering, QA, Manufacturing) to gather required technical inputs.
• Participate in root cause investigations and implement corrective and preventive actions (CAPAs) where applicable.
• Maintain accurate records of all remediation activities and ensure timely completion of assigned tasks.

Requirements

Qualifications :