Descripción y detalle de las actividades

Main Responsibilities
- Execute and lead supplier audits (on-site and remote) under ISO 13485, FDA 21 CFR Part 820, and MDSAP standards.
- Ensure proper implementation of APQP, PPAP, FMEA, Control Plans, and SPC at supplier sites.
- Manage SCAR/CAPA processes with a strong focus on root cause analysis (8D, DMAIC, 5 Whys), ensuring effective closure and prevention of recurrence.
- Validate critical supplier processes through IQ, OQ, and PQ, including special processes (molding, assembly, sterilization, etc.).
- Monitor and improve supplier performance metrics (PPM, OTD, NCR, COPQ).
- Lead Incoming Quality Control (IQC) activities and risk-based inspection plans (AQL, sampling plans).
- Actively participate on the production floor to ensure proper material release, containment of nonconformities, and line support.
- Manage engineering and supplier changes through Change Control processes (ECO/ECN).
- Collaborate with Manufacturing, Engineering, and Procurement teams to ensure supply chain robustness.
- Develop and qualify new suppliers,



including process audits and capability assessments.
- Ensure compliance with regulatory and customer requirements, including technical documentation, traceability, and validation.
- Support internal, external, and regulatory audits (FDA, Notified Bodies), including preparation of objective evidence.

Experiencia y requisitos

Requirements
- Bachelor’s degree in Industrial, Mechanical, Biomedical Engineering, or related field.
- 5+ years of experience as a Supplier Quality Engineer (SQE) in the medical device industry or a highly regulated environment.
- Strong hands-on experience on the production floor (manufacturing, quality, processes).
- Advanced English proficiency.

Technical Knowledge
- ISO 13485, FDA 21 CFR Part 820, MDSAP
- APQP, PPAP, FMEA, Control Plan
- SPC, MSA, statistical analysis
- CAPA, SCAR, 8D, Root Cause Analysis (RCA)
- Process validation (IQ/OQ/PQ)
- Change control (ECO/E

📌 Sr Supplier Quality Engineer (Tijuana)
🏢 Foxconn
📍 Tijuana