PURPOSE AND SCOPE:

Develops, implements, and maintains the activities of company quality systems and quality operations. Manages and oversees the activities of various levels of quality systems and quality operations staff.

 PRINCIPAL DUTIES AND RESPONSIBILITIES: Manages the tactical execution of short- and long-term quality systems and quality operations 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. Provides technical guidance.Manages the budget for Quality and stays within the approved budget target. Responsible for preparing and managing the budget for the Quality Department.Technically proficient in the specific quality department and knowledgeable of industry practice and business principles. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.  Oversees development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products.Oversees the Risk Management Program, Validation Committee, Acts as independent reviewer for design control activities, as assigned. Responsible for assigning designates for these responsibilities.Ensures risk management activities, process qualifications, and validations are appropriately performed and documented. Maintains knowledge of pre and post production quality planning, monitoring /trending, and internal audits.Ensures risk evaluations and risk reviews are performed in a timely manner and the risk management documents are updated accordingly. Ensures process changes are evaluated for impact on product and associated risk controls.Ensures the development and maintenance of data collection and analysis systems. Ensures the development, rationale, and review of process and product specifications, and sampling plans.Ensures the product release meets requirements and specifications.Ensures monthly trending is conducted on each product line and reported in the periodic meetings and monthly reports.Ensures and continuously improves the system for calibration at the facility. Supports other facilities within FMCNA. Ensures systems conform to company requirements and all applicable state, federal, and international regulations.Develops, implements, and continuously improves the system for process/software validation, and design transfer. Ensures these systems conform to company requirements and to all applicable state, federal, and international regulations.Manages FDA regulatory inspections, in conjunction with the Director, Quality Systems and Laboratory Operations of the facility.  Ensures that the facility's Quality System is established and maintained in compliance with applicable local ordinances, state statutes and Federal regulations, and other laws, including Title 21 CFR 820 (FDA Quality System Regulation).Assists in establishing quality specifications for incoming raw materials, in-process components, and finished medical devices. Ensures all quality specifications are met prior to release.Oversees review of device history records and associated documentation for release of finished product(s). Ensures all necessary documentation is completed and all specifications have been met prior to release of any product.Periodically reviews site training programs to verify that plant personnel are trained on GMP/QSR requirements. Ensures proper training and/or presents on quality systems topics.Ensures proper maintenance of Device Master Records and Device History Records for the site's products.  Reviews new documents, as well as changes to existing documents, to ensure enhanced quality and productivity.Performs trend analysis of data associated with quality problems to detect negative trends and to recommend corrective/preventive actions for problem resolution.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. Selects, develops and evaluates personnel to ensure the efficient operation of the function.Collaborates with internal and/or external resources to resolve problems of medium to high complexity in Quality issues.May report quality metrics to senior/executive management, as needed.Represents functional expertise at relevant department and site meetings, as needed.Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Interprets and recommends change to policies and establishes procedures that effect immediate organization(s).Makes recommendations for process improvements and participates in planning and implementing changes.Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers.Responsible for hiring, coaching, and counseling employees, including performance reviews, disciplinary action, and terminations.Interacts with internal departments and external customers; particularly in problem resolution. Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations. Assists with various projects as assigned. Other duties as assigned.   

 

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.  Works in an office environment and may be required to perform light lifting. This position involves sitting and or walking for considerable lengths of time. Bending to floor level is required.Travel up to 15% of the time required with the potential for additional travel, as needed.   SUPERVISION: Responsible for the direct supervision of various levels of quality staff. EDUCATION: Bachelor's Degree required, preferably in a scientific or engineering discipline; Advanced Degree desirable. EXPERIENCE AND REQUIRED SKILLS:        Minimum 6 - 8 years of related quality experience in a medical device/pharmaceutical environment.3+ years of supervisory experience preferred.Must be proficient with personal computer; strong skills with Microsoft Office software.Knowledge in relevant federal regulatory requirements.Strong attention to detail. Ability to drive results.Ability to train technical, professional, and managerial level personnel.Excellent verbal and written communication and strong interpersonal skills.Requires ability to function effectively in multiple team settings as well as independently and to manage multiple priorities.Knowledge of US cGMP/QSR, ISO 13485, and related Quality standards.Professional auditing certification (ASQ CQA, RAB, or equivalent) preferred. Six Sigma Green Belt preferred. Professional quality discipline certifications (ASQ CQE, CQM) desired.Strong knowledge of FDA regulatory requirements and of standard quality assurance practices for manufacturing operations.As applicable, strong knowledge of Health Canada GMPs.Remains current with industry standards and best practices.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.

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.