Sr Supplier Quality Engineer

Foxconn Baja California, S.A. de C.V.; Tijuana; Presencial; MXN 480.000 - 750.000; Jornada completa

Descripción de la vacante

Foxconn Baja California, S.A. de C.V. is seeking a seasoned Supplier Quality Engineer to lead supplier audits on-site and remotely, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP. You will drive APQP/PPAP, FMEA, Control Plans, SPC, and CAPA across supplier sites.

You will collaborate with Manufacturing, Engineering and Procurement to strengthen the supply chain, validate critical processes (IQ/OQ/PQ), and support regulatory audits with objective evidence.

Formación

• Bachelor’s degree in Industrial, Mechanical, Biomedical Engineering, or related field.
• 5+ years as a Supplier Quality Engineer in medical devices or regulated env.
• Strong hands-on production floor experience in manufacturing and quality.
• Advanced English proficiency.

Responsabilidades

• Execute and lead supplier audits on-site and remotely per ISO 13485, FDA 21 CFR Part 820, and MDSAP.
• Ensure APQP, PPAP, FMEA, Control Plans, and SPC at supplier sites.
• Manage SCAR/CAPA with root cause analysis (8D, DMAIC, 5 Whys) and prevent recurrence.
• Validate critical supplier processes via IQ, OQ, PQ including molding, assembly, sterilization.
• Monitor and improve supplier performance metrics (PPM, OTD, NCR, COPQ).
• Lead IQC activities and risk-based inspection plans (AQL, sampling).
• Support production floor material release, containment of nonconformities, line support.
• Manage engineering and supplier changes via ECO/ECN.
• Collaborate with Manufacturing, Engineering, Procurement for supply chain robustness.
• Develop and qualify new suppliers, including process audits and capability assessments.
• Ensure regulatory and customer documentation, traceability and validation.
• Support internal, external, regulatory audits (FDA, Notified Bodies) including objective evidence.

Conocimientos

SQE experience

Production floor exposure

Advanced English

Educación

Bachelor's degree in Industrial/Mechanical/Biomedical Engineering

Descripción del empleo

Main Responsibilities

1. Execute and lead supplier audits (on-site and remote) under ISO 13485, FDA 21 CFR Part 820, and MDSAP standards.
2. Ensure proper implementation of APQP, PPAP, FMEA, Control Plans, and SPC at supplier sites.
3. Manage SCAR/CAPA processes with a strong focus on root cause analysis (8D, DMAIC, 5 Whys), ensuring effective closure and prevention of recurrence.
4. Validate critical supplier processes through IQ, OQ, and PQ, including special processes (molding, assembly, sterilization, etc.).
5. Monitor and improve supplier performance metrics (PPM, OTD, NCR, COPQ).
6. Lead Incoming Quality Control (IQC) activities and risk‑based inspection plans (AQL, sampling plans).
7. Actively participate on the production floor to ensure proper material release, containment of nonconformities, and line support.
8. Manage engineering and supplier changes through Change Control processes (ECO/ECN).
9. Collaborate with Manufacturing, Engineering, and Procurement teams to ensure supply chain robustness.
10. Develop and qualify new suppliers, including process audits and capability assessments.
11. Ensure compliance with regulatory and customer requirements, including technical documentation, traceability, and validation.
12. Support internal, external, and regulatory audits (FDA, Notified Bodies), including preparation of objective evidence.

Requirements

1. Bachelor’s degree in Industrial, Mechanical, Biomedical Engineering, or related field.
2. 5+ years of experience as a Supplier Quality Engineer (SQE) in the medical device industry or a highly regulated environment.
3. Strong hands‑on experience on the production floor (manufacturing, quality, processes).
4. Advanced English proficiency.

Technical Knowledge

1. ISO 13485, FDA 21 CFR Part 820, MDSAP
2. APQP, PPAP, FMEA, Control Plan
3. SPC, MSA, statistical analysis
4. CAPA, SCAR, 8D, Root Cause Analysis (RCA)
5. Process validation (IQ/OQ/PQ)
6. Change control (ECO/ECN)
7. Sampling plans (AQL)
8. Traceability and technical documentation