Sr Manager, Quality Data Analytics

PURPOSE AND SCOPE:

Develops, implements, and maintains the activities of quality systems. Oversees development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Makes recommendations for corrective action necessary to ensure conformity with quality specifications. Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

​​Data Analytics:

• ​Leads efforts to develop system resolutions to report the credible data. 

• Analyze quality data reports for various internal customers and forums. 
• Generates advanced analytics and research from both external and internal data sources. 
• Assess potential product risks (from data reporting, prediction of performance and/or market observation and identified quality problems) 
• Provide support during creation and maintenance of quality reporting for leadership 
• Investigates complex data related issues and synthesizes quantitative and qualitative information using past, current, and future trending information. 
• One off report generation supporting business decisions or specific leadership requests. 
• Initiate analyses and investigations in terms of quality events/reports.
• Create actionable trend information and ensure that internal members of the company have the information necessary to make informed business, operating, and research decisions. 
• Ensure the appropriate timeliness, usability, and accuracy of the reports. 
• Measure and report the global quality performance of products and processes, through the product lifecycle, through the deployment of a global predictive reporting mechanism. 
• Audit quality data inputs for accuracy and consistent application of required measures. 
• Utilization of predictive analytics will support the identification and reporting of potential and actual quality related events. 
• Ensure the quality measurement system is consistently applied across global sites and validated/verified per regulatory requirements. 
• Deploy and maintain the global quality performance tracking and reporting process and tools supporting vertical (InCenter) global medical devices product conformity. 
• Establish best in class predictive quality product performance indicators and analytics globally across sites and products. 
• Interface with design and operations quality, and other functions, globally to ensure product performance and regulatory impacting measures are consistently gathered, reported, and analyzed. 

CAPA:

• Support evaluation and categorization of NC/CAPAs based on severity/criticality of the related
• Event. (Re-) Allocation of NC/CAPAs to involved parties and Investigation Units
• Follow up of NC/CAPA records regarding timeliness and quality/adequacy of investigation.
• Support Final review and closing of NC/CAPAs (as applicable)
• Support coaching to achieve compliance and efficient processes to execute CAPA records in a
• compliant manner.
• Utilize subject matter expertise in the areas of quality compliance to support the continuous improvement of the business.
• Develops and maintains effective relationships through effective and timely communication.
• Assists with the implementation, and continuous monitoring of quality compliance programs.
• Provides timely reports, both orally and in writing, regarding the status of the NC/CAPA Records for vertical.
• Collaborates with other departments at different stages of the record process (as applicable)

Other duties include.

• Establishes standard and meaningful objectives and metrics that align to goals, mission, and objectives for applicable department/program. Develops and distributes metrics to support the business.
• Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.
• Provides leadership, coaching, and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.
• Analyzes and reports on trends, and other areas of quality data on a periodic basis.
• Reports on key performance indicators associated with program effectiveness.
• Develops budgets, schedules, and performance standards. Exercises supervision in terms of costs, methods, and staffing.

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.
• While performing the duties of this job, the employee may be exposed to moving mechanical parts and vibration. Employee may be occasionally exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, extreme cold, extreme heat, and risk of electrical shock.
• The noise level in the work environment is usually quiet to loud.
• May occasionally be required to lift and/or move up to 50 pounds. 
• Travel 10% - 25%.

SUPERVISION:

May be responsible for the direct supervision of various levels of Quality Systems staff.

EDUCATION:

• Bachelor's Degree required, preferably in Science, Engineering, Quality Management, Technical, or Healthcare related field; Advanced Degree desirable.
• Professional quality discipline certification (CQE, CQA, CQM or RAB) desired.
• Member of PDA, AMMI, ASQ or other trade Association helpful.

EXPERIENCE AND REQUIRED SKILLS:          

• Minimum 6 or more years of related experience in quality systems, preferably quality engineering in the medical device manufacturing industry or pharmaceutical industry. Experience in quality assurance, regulatory affairs, compliance preferred.
• 3+ years of experience as a Manager preferred. Strong project management skills.
• Demonstrated ability to manage one or more departments.
• 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 820/210/211 and Part 11).
• Knowledge of ISO 13485 and Canadian Medical Device Regulations (CMDR).
• Prior experience with FDA inspections (back office, front office, host).
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Strong technical, business and relations skills directed related to a broad range of compliance areas.
• Must be able to interpret regulatory requirements, including FDA activity.
• Must be proficient with a personal computer; strong skills with Microsoft Office software.
• Experience with database software and design software. Knowledge of Crystal reporting. SAP experience desired.
• Understanding of document management, training design principles, curriculum development, adult learning theories, and training effectiveness.
• Knowledge of CAPA and NC system regulations and standards (i.e. ISO9001, ISO13485, FDA 21CFR) desired.
• Experience managing CAPAs in the Medical Device Industry desired.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.