C. R. Bard, Inc.

Quality Engineer

4 months ago
Industry / Category
Medical device manufacturing processes
Job ID
2016-9229
Career Level
experienced
Division
BOC REYNOSA
Relocation
no
Close Date
6/30/2016
MX-Reynosa

Overview

Responsible in assisting the Quality Manager on the department activities such as yearly goals, objectives, department budget, identify of the areas of opportunity, implement Quality Systems and maintain the facility within GMP compliance and FDA regulations. Develop and update the inspection procedures and methods used for product quality evaluation. Responsible for the Quality and compliance of new BPS converted lines. Develop and execute the product and process validation, conduct customer complaint evaluation and participate with the internal audits as needed.

Summary of Position with General Responsibilities

• Implement appropriate and efficient preventive and corrective actions to avoid problems
• Product and process validations within the facility and external suppliers (IQ/OQ & PQ) including testing equipment and tooling.
• Interact with corporate and divisional personnel to clarify specifications, product design changes, quality issues and line reconfigurations.
• Ensure GMP regulations and ISO and corporate guidelines are followed.

Basic Qualifications

Knowledge & Training: Knowledge in statistical techniques, GMP’s and QA basics, QSR and ISO requirements. Green Belt Cert. desired

Competences: Fluent English, strong writing skills, self-administer, well organized, computer literacy, leadership, results oriented.

Education and/or Experience

Experience: 5 Years related experience in quality system, including experience on medical device manufacturing processes.

Work Environment

Positive work enviroment

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