Compliance Officer – Medical Devices (EMS)
Grupo TECMA
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.
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