Position Title : Supplier Quality Engineer

Responsibilities

- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirement

- Lead and support internal and external audits, including FDA, Notified Body, and customer or supplier audits.

- Maintain and improve Quality Management System (QMS) procedures and documentation

- Lead investigations for nonconformances (NCRs), complaints, and CAPA activities using structured problem‑solving tools (e.g., 5 Why, Fishbone, DMAIC)

- Ensure timely closure and effectiveness verification of supplier corrective and preventive action

- Support risk assessments for changes, process changes, and nonconformities

- Review and approve supplier IQ/OQ/PQ validation protocols and reports

- Ensure statistical techniques (e.g., Gage R&R;, SPC, sampling plans) are correctly applied by supplier

- Collaborate with cross‑functional teams (Engineering, Manufacturing, RA, Supply Chain)



to support timely implementation of activities related to validation or supplier quality concerns

- Develop and track quality metrics (e.g., scorecard, supplier NCs, MRB)

- Supervise suppliers’ quality performance, push suppliers to improve their performance

- Manage and improve IQC & SQE document.

Qualification:

- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other general regulatory standards

- Experience with risk management per ISO 14971.

- Proficiency in process validation (IQ/OQ/PQ), test method validation, and equipment qualification.

- Knowledge of statistical analysis and tools: SPC, Minitab, Gage R&R;, sampling plans (ANSI/ASQ Z1.4).

- Experience working with QMS systems, documentation control, and audit readiness.

- Understanding of manufacturing processes, process controls, and defect prevention.

- Familiarity with design control and DHF/DMR requirements.

📌 Supplier Quality Engineer (México)
🏢 Quasar Medical | Medical Device Manufacturer
📍 México