Manager, Quality and Compliance

GoCheck Kids is a mission driven B2B health tech company dedicated to making a significant impact on children's lives by detecting health issues early on. Our innovative technology is revolutionizing the way health issues are identified and addressed, ensuring children receive the care they need at the earliest possible stage.

The Quality & Compliance Manager leads all aspects of the company’s Quality Management System (QMS), including compliance with FDA regulations, ISO 13485, and internal standards. This individual owns and operates the quality system, supervises a small team of specialists, and serves as the primary interface with regulators and auditors. The role blends strategic QMS leadership with hands‑on execution across CAPA, document control, design changes, supplier management, complaint handling, internal audits, and production quality.

This is a key cross‑functional role working closely with manufacturing, engineering, product development, and executive leadership to ensure both operational quality and regulatory readiness. The Quality & Compliance Manager executes core QMS tasks personally, while also delegating operational tasks to a small team of specialized Quality & Compliance staff (e.g. QC Inspector, Compliance Specialist, etc). This role is highly hands‑on in daily quality operations.

The Quality & Compliance Manager is a full‑time role based at our manufacturing office in Nashville, TN.

This role reports to the Chief Operating Officer with a high degree of autonomy in leading quality and compliance activities.

To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned.

• Lead the development, maintenance, and improvement of QMS procedures and documentation in accordance with FDA QMSR and ISO 13485.
• Manage and execute the CAPA process, including root cause analysis, effectiveness verification, and coordination of the CAPA Review Board (CRB).
• Oversee the Document and Change Control process, including execution of daily tasks for Document/Change Control and Control of Quality Records, and periodic reviews of controlled documents.
• Support design transfer activities by completing Design Transfer deliverables associated with software releases and new product introduction.
• Manage the Supplier Quality Management Program, including maintenance of the Approved Supplier List (ASL) and supplier evaluations.
• Oversee and execute the Product Returns processes, including returns dispositioning.
• Management of Nonconforming Product process, including coordination of MRB.
• Ensure compliance with manufacturing‑related QMS processes, including management of Production and Process Controls, Equipment Controls, Quality Control Inspections and other Quality Operations processes to ensure on‑going compliance at Manufacturing site.
• Manage the company’s Internal Audit Program, including planning, execution of daily tasks, reporting, and follow‑up activities.
• Maintain and administer the company’s Quality Training Program, including development of content and management of training records.
• Supervise Quality and Compliance personnel, providing mentorship, task delegation, and performance feedback.
• Prepare and facilitate periodic Quality Management Review meetings, including data compilation, reporting, coordination, preparation and minutes.
• Serve as the designated Quality Management Representative, ensuring the QMS is effectively implemented, maintained, and reported to top management. This individual has authority to raise compliance concerns directly to Board of Directors.

• Act as the company’s Front Room lead during external audits and inspections by FDA and other External…