Track and ensure employee training on procedures, regulations, and device handling.

Manage device specifications, manufacturing processes, labelling, packaging and quality control procedures.

Control, track and manage documents required for compliance with FDA Part 820 and ISO 13485.

Ensure devices meet predefined specifications, with proper documentation, review, and approval of changes & revisions by the right people.

Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.

Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.

Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.

Plan, schedule, and conduct internal, layered and external audits for compliance verification.

Implement approval workflows within the QMS that allow for electronic signatures in compliance with 21 CFR Part 11 requirements.

Validate that product design and production processes produce items meeting specified design requirements.

Keep a history of all design inputs, outputs, verification/validation activities & risk management.

Manage device's lifecycle stages from design through obsolescence with a focus on quality control.

Capture critical batch info such as materials used, manufacturing steps, calibration, QC tests, batch releases.

Ensure adherence to relevant regulatory requirements, such as FDA 21 CFR Part 820, ISO 13485, MDR (Medical Device Regulation), and other applicable standards.

Controlled management of changes to device design or production process with proper review and approval.

Identify, document, and resolve non-conformities; implement corrective/preventive actions.

Manage the qualification, evaluation, and monitoring of suppliers, including conducting supplier audits, tracking supplier performance, and maintaining supplier documentation.

Identify and discuss failure modes, causes, effects, severity, detection, risk priorities of your product, design & process

Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.

Generate reports, dashboards, and analytics on key quality metrics, performance indicators, and trends to enable data-driven decision-making.

Integrate with other systems and tools, such as ERP systems, CRM systems, and collaboration platforms to facilitate seamless information exchange and workflow management.