Job Information
Fresenius Medical Care North America Sr. Principal CAPA in Waco, Texas
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 duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS :
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
May be required to sit and walk for considerable lengths of time.
Bending to floor level is required.
SUPERVISION:
- None
EDUCATION AND REQUIRED CREDENTIALS:
- Bachelor’s Degree required, preferably in Science, Engineering, Technical, or Healthcare related field. Advanced Degree desirable.
EXPERIENCE AND SKILLS: (Add any additional requirements, as needed)
Minimum 12 years of recent experience within a quality systems role in the medical device/pharmaceutical industry
Strong project management skills.
Demonstrated ability to mentor and train one or more employees.
Ability to generate moderately complex spreadsheets with graphs for trending data and presentations.
Knowledge and application of metrics and charts for quality system processes.
Strong written and verbal communication skills. Ability to communicate effectively with and influence others at different levels of the organization. Ability to write speeches and articles using original or innovative techniques or style.
Must have a solid understanding of the regulations governing medical devices and pharmaceutical products.
Knowledge of FDA regulatory requirements (21 CFR Part 806/820/210/211 and Part 11).
Experience with FDA compliance actions (FDA 483/Warning Letter)
Knowledge of ISO 13485 and Canadian Medical Device Regulations (CMDR).
Strong technical, business and relations skills directed related to a broad range of compliance areas.
Must be proficient with a personal computer, strong skills with Microsoft Office software.
Knowledge of CAPA and NC system regulations and standards (i.e. ISO9001, ISO13485, FDA 21CFR) required.
Experience managing CAPAs in the Medical Device Industry required.
Six Sigma Green Belt/Advance Root Cause Analysis expertise required.