Quality Specialist (Remediation)

Job Summary:

We are seeking experienced Quality Specialist with experience in remediation project to support critical remediation activities within a regulated manufacturing environment. The selected candidate 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 nonconformances 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.

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.
• Excellent attention to detail, organizational skills, and ability to work independently with minimal supervision.
• Languages: Proficient in Spanish and English