Quality Assurance Engineer — CAPA & GMP (Hybrid)

Medline

Mexicali

Hybrid

MXN 240,000 - 360,000

Full time

3 days ago

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Job summary

Medline Mexicali is seeking a QA Engineer to lead CAPA activities for customer complaints, address non-conformities, and support GMP compliance in a hybrid work environment. You will analyze quality data, perform PFMEAs, develop measurement equipment and control plans for warehouse to operations, and drive continuous improvement projects in a manufacturing setting.

Required: Bachelor's in Manufacturing or Industrial Engineering and 1–3 years in quality control/engineering, with medical device

Qualifications

Bachelor's degree in Manufacturing, industrial or related field.
1–3 years of Quality Control/Engineering experience.
Internal/Lead Auditor ISO 13485:2016 experience.

Responsibilities

Lead and coordinate CAPA for customer complaints and non-conformities.
Communicate product quality issues, data analysis, trends to internal customers.
Perform PFMEAs and continual process reviews to improve quality.
Develop plans to identify trends in customer complaints and in-process non-conformances.
Develop measurement equipment to evaluate component inspections.
Define control plans for warehouse-to-operations delivery of raw materials.
Lead continuous improvement projects focusing on quality and cost reduction.
Audit component storage accuracy and communicate results to warehouse personnel.
Support GMP implementation and improvements.
Communicate progress with peers, internal customers, suppliers and management.
Maintain communication with Corporate counterparts.