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:

• 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.
• 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.
• 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.
• Analyzes and reports on trends, and other areas of quality data on a periodic basis.
• Reports on key performance indicators associated with program effectiveness.
• Generally manages department budget and day-to-day functions. Develops budgets, schedules and performance standards.  Exercises supervision in terms of costs, methods, and staffing.
• Ensures goals and objectives are aligned between Corporate and sites, including those of the Corporate QMS.
• Interacts frequently with internal departments and external customers/vendors; particularly in problem resolution. Responsible for hiring, coaching, and counseling employees, including performance reviews, disciplinary action and terminations.
• 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, for all manufactured and distributed products, quality system processes, and applicable services.
• Keeps up-to-date on new regulations and standards that affect the program.
• Ensures the development and maintenance, as appropriate, of data collection and analysis systems including the development, rationale, and review of process and product specifications.
• Ensures the establishment of accurate and robust company, site, department, and role-based training requirements/assignments.
• May assist corporate and various sites with the preparation of regulatory responses and periodic updates.
• Provides technical guidance.
• 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.
• 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:

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 - 8 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.

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