Medical Device Quality Systems & FDA Inspection Readiness Consultant

Job Description

Job Description

Medical Device Quality Systems & FDA Inspection Readiness Consultant

Location: Atlanta/Duluth, Georgia area
Work Arrangement: Onsite
Duration: Immediate start through November 2026, with potential extension
Start: Immediate

Position Overview

We are seeking an experienced Medical Device Quality Systems Consultant to provide hands-on support for the startup of a new Class I medical device contract manufacturing operation.

The consultant will support Quality Management System (QMS) implementation, development of auditable quality and operational processes, system validation, and FDA inspection readiness. A key focus will be ensuring appropriate controls are established across production, warehousing, inventory, traceability, product hold/quarantine, release, and direct-to-consumer distribution activities.

The engagement will require both quality systems expertise and practical implementation support as the organization works toward regulatory and operational milestones in October and a planned November 1 go-live. The consultant may also provide training and ongoing Quality support following launch.

Key Responsibilities

• Review the existing QMS and tailor requirements and processes for the new medical device manufacturing operation.

• Support implementation of the QMS and ensure processes are operational, documented, and auditable.

• Develop new quality and operational processes needed to support manufacturing and distribution activities.

• Support validation of the warehouse management system and associated workflows.

• Establish and/or assess controls for production, inventory management, product traceability, quarantine/hold, and product release.

• Develop appropriate quality checks and controls for direct-to-consumer product shipments.

• Assess Quality System and operational readiness for an anticipated FDA inspection.

• Identify inspection-readiness gaps and support implementation of corrective actions before go-live.

• Work directly with facility personnel to operationalize new procedures and quality controls.

• Provide employee training and implementation support for new or revised processes, as needed.

• Support the organization through its planned November 1 launch and provide ongoing Quality support following go-live, as needed.

Required Qualifications

• Significant medical device Quality or Quality Systems experience.

• Demonstrated experience implementing or adapting a QMS for medical device operations.

• Strong knowledge of FDA medical device quality requirements and inspection readiness.

• Experience developing and implementing auditable quality and operational processes.

• Experience with warehouse, distribution, inventory, traceability, quarantine/hold, and product release controls.

• Experience supporting computerized system validation or validation of warehouse/inventory management systems.

• Ability to provide hands-on implementation support and work directly with site personnel.

• Ability to work onsite in the Atlanta/Duluth, Georgia area.

Preferred Qualifications

• Experience supporting startup or launch activities for a medical device manufacturing operation.

• Experience with Class I medical devices.

• Experience establishing quality controls for direct-to-consumer distribution.

• Local to the Atlanta/Duluth, Georgia area.

Work Arrangement

This engagement requires onsite support in the Atlanta/Duluth, Georgia area. Local consultants are preferred to facilitate consistent onsite support.

Ideal Candidate

The ideal consultant is a hands-on Medical Device Quality Systems professional with experience taking QMS requirements from documented procedures through practical implementation. The consultant should be comfortable working across quality systems, warehouse and distribution controls, system validation, and FDA inspection readiness while helping a new manufacturing operation prepare for launch.