Compliance Officer – Medical Devices (EMS)

Quality & Regulatory Compliance

• Own and maintain the site Quality Management System (QMS) in alignment with:
• FDA QMSR (21 CFR 820 – ISO 13485:2016 aligned)
• ISO 13485 and applicable global regulations
• Monitor and implement regulatory updates (FDA, ISO, international) and translate them into actionable site requirements.
• Ensure QMS documentation is current, effective, and audit-ready.

Audits & Inspections

• Lead and host:
• FDA inspections
• ISO / registrar audits
• Customer audits (medical device OEMs)
• Own audit preparation, execution, response, and closure.
• Develop and track CAPAs to ensure root cause effectiveness and prevention of recurrence.

Risk Management & CAPA

• Ensure robust risk management practices across:
• Manufacturing processes
• Material changes
• Supplier changes
• Lead investigations for quality events, deviations, and escapes.
• Ensure CAPAs are data-driven, systemic, and aligned with regulatory expectations.

Supplier & External Compliance

• Oversee supplier qualification, audits, and ongoing monitoring.
• Ensure compliance related to:
• Outsourced processes
• Critical suppliers
• Cybersecurity considerations impacting QMS (as applicable)

Manufacturing & Operations Interface

• Partner closely with Manufacturing Engineering, Quality, Supply Chain, Operations.
• Ensure compliance is embedded in day-to-day operations (IQC, MRB, change control, product release).
• Support NPI, transfers, and special builds from a compliance and risk standpoint.

Export & Medical Device Shipping Compliance

• Ensure regulatory compliance for export of medical devices to the U.S. and other markets.
• Verify documentation integrity for product release and shipment.
• Support regulatory requirements related to combination products if applicable.

Training & Culture

• Develop and deploy compliance and regulatory training across the organization.
• Build a strong quality culture focused on prevention, discipline, and accountability.
• Act as a mentor and subject-matter expert for Quality and Engineering teams.