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.). Key Competencies Regulatory authority and credibility. Strong judgment and decision-making. Clear, executive-level communication. Ability to balance compliance with operational realities. High sense of ownership and accountability. Calm and effective under audit pressure. #J-18808-Ljbffr