Senior Manager, Quality Systems
Senior Manager, Quality Systems, Fresenius USA Manufacturing, Inc., a Fresenius Medical Care N.A. company, Ogden, Utah.
Responsible for developing, implementing, and maintaining quality systems activities. Oversee development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company medical products.
- Making recommendations for corrective action necessary to ensure conformity with quality specifications, ensuring finished products conform to government and company standards, and ensuring that good manufacturing practices regulations are being properly followed.
- Managing tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.
- Providing leadership, coaching, and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.
- Developing, modifying, and executing company policies and procedures that affect immediate operations with potential company-wide effect.
- Implementing strategic policies when selecting methods, techniques and evaluation criteria for obtaining results.
- Establishing standard and meaningful objectives and metrics that align to goals, mission and objectives for applicable department/program.
- Developing and distributing metrics to support the business.
- Analyzing and reporting on trends, and other areas of quality data on a periodic basis.
- Reporting on key performance indicators associated with program effectiveness.
- Generally managing the department budget and day-to-day functions by developing budgets, schedules and performance standards.
- Exercising supervision in terms of costs, methods and staffing.
- Ensuring goals and objectives are aligned between Corporate and sites, including those of the Corporate QMS.
- Hiring, coaching, and counseling employees, including performance reviews, disciplinary action and terminations.
- Remaining current with industry standards and best practices to promote activities necessary for the evolution of the quality management system.
- Ensuring procedures are clearly defined and implemented to fulfill regulatory and business requirements and identifying areas for continuous improvement of these procedures (best in class).
- Ensuring documents are properly maintained, with good documentation practices, for all manufactured and distributed products, quality system processes and applicable services.
- Ensuring the development and maintenance, as appropriate, of data collection and analysis systems including the development, rationale, and review of process and product specifications.
- Ensuring the establishment of accurate and robust company, site, department and role-based training requirements/assignments.
- Assisting corporate and various sites with the preparation of regulatory responses and periodic updates.
Education Experience and Required Skills:
This position requires a Bachelor’s degree (or equivalent foreign degree) in Chemical Engineering, Biological Engineering, Biomedical Engineering, or a closely related field and 7 years of experience providing Quality Systems oversight for medical device and pharmaceutical products. Experience, which may have been gained concurrently with the primary experience requirement listed above, must include 5 years of experience with: (I) Performing quality systems analysis in support of medical device products and ensure all products and processes comply with applicable regulations, including specifically cGMP regulations and ISO guidelines; (II) Providing recommendation for corrective action and preventative actions (CAPA, and implementing continuous improvement processes); (III) drafting and preparing regulatory response and periodic updates of company products; (IV) developing budgets and capital requests as well as internal performance standards; and (V) Managing regional quality improvement projects.