Ingeniero Sr. Calidad (CAPA)

Medline; Nuevo Laredo; Hybrid; MXN 420,000 - 540,000; Full time

Job summary

Medline in Nuevo Laredo, Mexico seeks a Quality Engineer to execute and coordinate QA functions in a fast-paced corporate environment.

You will lead CAPA for customer complaints, analyze data, and drive continuous improvement projects while ensuring GMP compliance and strong cross-functional communication in English and Spanish.

Qualifications

• Bachelor's degree in Engineering or related field preferred.
• 3–5 years quality control experience in regulated industry preferred.
• Six-Sigma Black Belt or Green Belt.
• Strong written and verbal English and Spanish skills.

Responsibilities

• Lead and coordinate CAPA for customer complaints and non-conformities.
• Communicate product quality issues, data, trends, and information to internal customers.
• Conduct PFMEA-based process reviews and improvement initiatives.
• Develop plans to identify trends from customer complaints and in-process issues.
• Define measurement equipment and control plans for warehouse to operations.
• Lead continuous improvement projects focused on quality and cost reductions.
• Perform periodic audits of component storage locations and communicate results.
• Support implementation and improvements for GMPs.

Skills

Leadership

Communication

Self-initiative

Attention to detail

Time management

Critical thinking

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Excel

Microsoft Word

Job description

**Job Description****General Objective:**This position executes and coordinates Quality Engineering functions for the organization. The position requires a dynamic, hard-working quality professional with a desire to work for a fast-paced, large corporate organization. In addition to exceptional communication skills, a “roll-up” your sleeves” entrepreneurial attitude is expected.**Responsabilities:*** Lead and coordinate Corrective and Preventive Actions (CAPA) for Customer complaints, and process non-conformities.* Communicate product quality issues, data analysis, trends, and/or other information to respective internal customers.* Continual process reviews through the use of the defined process failure mode analysis (PFMEAs) documents.* Develop processes and plans to identify trends and focus on customer complaints, and in-process non-conformances.* Develop and define measurement equipment to evaluate and perform component inspections.* Define effective control plans for warehouse to operations delivery of raw materials’ processes.* Define, and lead continuous improvement projects focused on quality improvement, and cost reductions.* Perform periodic audits of the accuracy and cleanliness of component storage locations and communicate results with appropriate warehouse personnel.* Support the implementation and improvements for Good Manufacturing Practices (GMPs).**Experience:*** Bachelor’s degree in Engineering or business-related field preferred.* At least 3 - 5 years of quality control related work required.* Preferably in a regulated industry (Medical Device, Pharmaceutical, Food or Personal Care).* Supervisory experience preferred but not mandatory.* Intermediate level skill in Microsoft Excel and Word* Six-Sigma Black Belt of Green Belt* Knowledge in Lean Manufacturing concepts* Strong written and verbal English and Spanish skills.**Skills:*** Strong leadership skills* Effective communication* Self-iniative* Excellent attention to detail and time managment skills* Ability to critically think about situations and independently make decisions.