Medical Device Quality Remediation Consultants (Hybrid)

Medical Device Quality Remediation Consultants

Location: North of Fort Worth, TX
Work Arrangement: Primarily Onsite / Hybrid Flexibility
Duration: Initial 3-month engagement with potential extension to 6+ months
Openings: 2 Consultants
Start: ASAP / Within the next few weeks
Schedule: Full-time preferred; qualified part-time consultants may also be considered

Position Overview

We are seeking two experienced Medical Device Quality Remediation Consultants to support a quality systems remediation initiative at a medical device organization in Texas.

The consultants will provide hands-on support addressing CAPA and complaint backlogs, FDA remediation activities, quality and regulatory records, and implementation of FDA Quality Management System Regulation (QMSR) requirements.

This engagement requires professionals who can move beyond high-level strategy and actively drive remediation activities through completion. The ideal consultants will be able to identify root causes, develop practical and sustainable corrective actions, and work collaboratively with site personnel to strengthen the overall Quality Management System.

Key Responsibilities

• Drive investigation, remediation, and closure of open and aging CAPAs.
• Address existing complaint-handling backlogs and support timely closure of complaint records.
• Evaluate and improve complaint-handling processes to promote sustainable compliance.
• Perform and/or support root-cause investigations and development of effective corrective actions.
• Support remediation activities resulting from FDA inspection observations.
• Assist with quality and regulatory record management and remediation.
• Support implementation and integration of FDA QMSR requirements into the existing Quality Management System.
• Ensure remediation activities align with applicable FDA requirements and ISO 13485.
• Identify systemic quality issues and develop practical corrective actions that address underlying causes rather than short-term fixes.
• Collaborate with Quality, Regulatory, Operations, and other cross-functional stakeholders to drive remediation activities to completion.

Required Qualifications

• Significant medical device industry experience.
• Strong working knowledge of ISO 13485.
• Strong knowledge of 21 CFR Part 820 and FDA QMSR requirements.
• Demonstrated hands-on experience with CAPA remediation and closure.
• Strong complaint handling and complaint investigation experience.
• Experience supporting remediation following FDA inspections and observations.
• Experience with quality records and regulatory documentation.
• Strong root-cause analysis, investigation, and problem-solving capabilities.
• Ability to develop sustainable, compliant solutions and effectively drive them through implementation.
• Comfortable working in a hands-on consulting environment with significant interaction with site personnel.

Work Arrangement

This engagement will require frequent onsite presence in Texas. Some administrative and documentation activities may be completed remotely when appropriate.

Local candidates are preferred; however, travel can be accommodated for highly qualified consultants who are not located in the area.

Ideal Candidate

The ideal consultant is a seasoned medical device Quality Systems/Remediation professional with substantial hands-on experience in CAPA, complaints, FDA remediation, ISO 13485, and FDA QMSR/21 CFR Part 820.