Ingeniero Sr. Calidad (CAPA)

Posted 2 Days Ago
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Nuevo Laredo, Tamaulipas, MEX
In-Office
Senior level
Other
No.1 privately held manufacturer & distributor of health care products in the U.S.
The Role
Lead and coordinate CAPA and non-conformity processes, analyze quality data and trends, implement PFMEAs and control plans, perform audits, support GMP implementation, and drive continuous improvement projects to reduce costs and improve product quality.
Summary Generated by Built In

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.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.

Skills Required

  • Bachelor's degree in Engineering or business-related field
  • 3-5 years of quality control related work
  • Experience in a regulated industry (Medical Device, Pharmaceutical, Food or Personal Care)
  • Supervisory experience
  • Intermediate level skill in Microsoft Excel and Word
  • Six Sigma Black Belt or Green Belt
  • Knowledge of Lean Manufacturing concepts
  • Strong written and verbal English and Spanish skills
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The Company
HQ: Northfield, IL
20,000 Employees
Year Founded: 1961

What We Do

All across America and the world, we help healthcare systems improve patient outcomes and reduce costs through clinical and financial solutions. As both a manufacturer and distributor of medical devices and supplies, we’re made up of problem solvers. Risk-takers. Big thinkers and doers.

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