Compliance Officer – Medical Devices
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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
Required Qualifications
- Bachelor’s degree in Engineering, Quality, Regulatory Affairs, or related field.
- 7+ years of experience in medical device manufacturing or EMS with strong regulatory exposure.
- Deep, hands-on knowledge of:
- FDA 21 CFR 820 / QMSR
- ISO 13485:2016
- Proven experience leading FDA and customer audits.
- Strong background in CAPA, risk management, and change control.
- Experience working with international customers and corporate stakeholders.
- Fluent English (written and spoken) – required for audits and executive communication.
Preferred Qualifications
- Experience in EMS or high-mix / low-volume medical manufacturing.
- Prior interaction with FDA investigators.
- Experience supporting FDA registrations and site readiness.
- Familiarity with MDSAP (preferred, not required).
- Strong understanding of cybersecurity considerations within QMS.
- Certification in Quality or Regulatory disciplines (ASQ, RAPS, etc.).
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