Senior Validation Quality Engineer

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Jacksonville, Florida, United States of America

Job Description:

Johnson & Johnson, Vision a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Validation Quality Engineer, Quality Operations.

This position will be located in Jacksonville, FL

Position Summary:

The Senior Quality Engineer is primarily responsible for ensuring operational compliance to FDA/GMP and ISO 9001 regulations.

Analyzes quality trends and reports conclusions.

Reviews and applies trend results to prioritize resolution of process, equipment and/or system problems in order to prevent re-occurrence.

Utilizes tools to track quality performance and identify key opportunities.

In addition, the Sr.

Quality Engineer provides support in the planning, development, implementation, and maintenance of the quality management systems, policies, documentation, data and processes.

Key Responsibilities:


* Facilitates complex validation activities within product, process, equipment, software and facilities changes and ensures all activities are consistent with regulations and validation policies and procedures.

( 30%)



* Utilizes quality tools to track and trend quality performance and identify key opportunities for improvement.

Applies trend results to help prioritize the resolution of equipment, systems or processes to prevent recurrence.

(15%)



* Applies a risk-based approach to validation strategy and evaluate change request assessments ( 10%)



* Represents quality assurance in validation for multi-departmental meetings, change control, and project teams as needed.

(10%)



* Compiles data and provides reports to management on a periodic basis.

(10%)



* Formulates quality policies and procedures and conducts training on quality concepts and tools and systems as necessary (5%%)



* Review and support updates to quality documentation and procedures.

(5%)



* Develops sampling plans by applying attribute, variable, and sequential sampling methods.

(5%)



* Performs other related duties as assigned by ...