Quality Remediation Specialist (Medical Device)

Job Title: Quality Remediation Specialist (Medical Device Industry)

Location: North Puerto Rico (Open to residents of Puerto Rico)

100% Onsite Opportunity

Positions Available: 8

Duration: Approximately 6 months

Job Summary

ProQuality Network is seeking four experienced Quality Remediation Specialist to represent our team on-site at our client’s regulated Medical Device manufacturing facility. These professionals will play a critical role in executing quality remediation activities to support compliance and process improvements. This opportunity involves working in a fast-paced, highly regulated environment, ensuring alignment with FDA, ISO 13485, and GMP standards.

This position is expected to start as soon as possible, with a project duration determined by our client’s ongoing needs.

Key Responsibilities

• Evaluate and qualify product and process rework activities in accordance with approved protocols and applicable regulatory requirements.
• Review, revise, and update controlled documents such as SOPs, work instructions, protocols, and batch records.
• Support risk assessments and impact evaluations for historical deviations and nonconformances.
• Ensure all documentation reflects traceability, scientific justification, and alignment with regulatory expectations.
• Collaborate with cross-functional teams, including Engineering, QA, and Manufacturing, to obtain required technical inputs.
• Participate in root cause investigations and assist in the implementation of corrective and preventive actions (CAPAs).
• Maintain comprehensive records of remediation work and ensure timely completion of assigned deliverables.

Qualifications

• Bachelor’s degree in Engineering or a related technical field (or equivalent industry experience).
• Minimum of 2 years of experience in quality assurance, quality systems, or remediation within a regulated industry such as pharmaceuticals, biotech, or medical devices.
• In-depth understanding of GMP, FDA regulations, and ISO 13485.
• Hands-on experience with rework validation, document control, and risk-based decision-making processes.
• Proficiency with electronic Quality Management Systems (eQMS) and document control platforms.
• Strong attention to detail, excellent organizational skills, and the ability to work independently with minimal supervision.
• Bilingual (Spanish and English proficiency required).

If you are interested in contributing your expertise in a meaningful way while supporting quality and compliance efforts in the Medical Device sector, we encourage you to apply through the job description link with your updated resume.