Quality & Regulatory ComplianceOwn and maintain the site Quality Management System (QMS) in alignment with:FDA QMSR (21 CFR 820 – ISO *****:**** aligned)ISO ***** and applicable general regulationsMonitor and implement regulatory updates (FDA, ISO, international) and translate them into actionable site requirements.Ensure QMS documentation is current, effective, and audit-ready.Audits & InspectionsLead and host:FDA inspectionsISO / registrar auditsCustomer 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 & CAPAEnsure robust risk management practices across:Manufacturing processesMaterial changesSupplier changesLead investigations for quality events, deviations, and escapes.Ensure CAPAs are data-driven, systemic, and aligned with regulatory expectations.Supplier & External ComplianceOversee supplier qualification, audits, and ongoing monitoring.Ensure compliance related to:Outsourced processesCritical suppliersCybersecurity considerations impacting QMS (as applicable)Manufacturing & Operations InterfacePartner 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 ComplianceEnsure 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 & CultureDevelop 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 QualificationsBachelor's degree in Engineering, Quality, Regulatory Affairs, or related field.7+ years of experiencein medical device manufacturing or EMS with strong regulatory exposure.Deep, hands-on knowledge of:FDA 21 CFR 820 / QMSRISO *****:****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 QualificationsExperience 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 CompetenciesRegulatory 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.

📌 Compliance Officer – Medical Devices (Ems) (Tijuana)
🏢 Grupo TECMA
📍 Tijuana