Sr. Principal CAPA

PURPOSE AND SCOPE:

Supports FMCNA's mission, vision, core values and customer service philosophy.  Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements.

As subject matter expert provides regulatory compliance expertise on the analysis and investigation of product quality issues with the intent of solving complex product and quality system compliance issues.  Provides quality expertise to QS/RA functions and to all RTG manufacturing locations as required, based on both in-process manufacturing and post-market quality analyses.

PRINCIPAL DUTIES AND RESPONSIBILITIES:


* Has broad expertise or unique knowledge; uses skills to contribute to the development of company objectives and principles, and achieve goals.


* Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs and methods



* Provides expertise and guidance on Quality Systems and CAPA methodology to maintain companywide compliance to procedures and regulations


* Provides expertise, guidance, and training on Root Cause Analysis and CAPA techniques for corporate and sites.


* Interprets company-wide policies and procedures.

Involved in the development, modification, and execution of company policies that affect immediate operations with potential company-wide effect.

Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.


* Analyzes and reports on trends, and other areas of quality data on a periodic basis.


* Interacts frequently with internal departments and external customers/vendors; particularly in problem resolution.


* Remains current with industry standards and best practices to promote activities necessary for the evolution of the quality management system.


* Ensures procedures are clearly defined and implemented to fulfill regulatory and business requirements.

Identifies areas for continuous improvement of these procedures (best in class).


* Ensures documents are properly maintained, with good documentation practices, and aligned with regulatory requirements for CAPA and related quality systems


* Keeps up-to-date on new regulations and standards that affect the Quality System


* Ensures the development and maintenance, as appropriate, of data collection and analysis systems including the development, rationale, and review of process and product specifications.


* May provide leadership and direction to other staff/assigned resources.


* Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.

Exercises judgment in methods, techniques, and evaluation criteria for obtaining results.


* Acts independently to determine methods and procedures on new or special assignments. 


* Assists with various projects as assigned.


* Other...