QA Engineer - Medical Devices, CAPA & GMP Focus

Medline; Mexicali; Híbrido; MXN 279.000 - 469.000; Jornada completa

Descripción de la vacante

Medline Industries, LP in Mexicali is seeking a QA Engineer to lead CAPA activities, perform PFMEA reviews, and ensure GMP compliance across manufacturing and packaging operations in a hybrid role. The position requires a Bachelor’s degree in Manufacturing or Industrial Engineering and 1–3 years ofQuality Control/Engineering experience within medical devices, plus ISO 13485:2016 auditing exposure.

Fluency in English is essential.

Formación

• Bachelor's degree in Manufacturing, industrial engineering or a related field.
• 1-3 years of Quality Control/Engineering experience.
• Experience with Medical Devices and ISO 13485:2016 internal/lead auditing is required.

Responsabilidades

• Lead and coordinate CAPA for customer complaints and process non-conformities.
• Communicate product quality issues, data analysis, trends to internal customers.
• Continual process reviews via PFMEA documents.
• Develop processes to identify trends and focus on customer complaints and in-process non-conformances.
• Define measurement equipment to evaluate inspections.
• Define effective control plans for warehouse to operations delivery of raw materials.
• Lead continuous improvement projects focused on quality and cost reductions.
• Perform periodic audits of storage locations and communicate results to warehouse personnel.
• Support GMP implementations and improvements.
• Maintain communication with peers, internal customers, suppliers and management on progress.

Conocimientos

Bilingual (English)

Effective communication

Team collaboration

Self-motivated

Lean manufacturing

Six Sigma

Quality focus

Educación

Bachelor's degree in Manufacturing, industrial or related field

Descripción del empleo

Medline Industries, LP in Mexicali is seeking a QA Engineer to lead CAPA activities, perform PFMEA reviews, and ensure GMP compliance across manufacturing and packaging operations in a hybrid role. The position requires a Bachelor’s degree in Manufacturing or Industrial Engineering and 1–3 years ofQuality Control/Engineering experience within medical devices, plus ISO 13485:2016 auditing exposure.

Fluency in English is essential.