PURPOSE AND SCOPE:

Responsible for quality planning, internal audits, data collection and analysis, specification development and review and design review and qualification. Works with cross-functional teams to develop, commercialize, and maintain high quality, innovative and compliant devices by ensuring compliance to design controls, leading and supporting product testing and risk management, generating procedures, and serving as a key resource for associated standards and requirements.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Under close supervision, utilizes established procedures to perform routine assigned tasks
• Familiarity with quality records and the ability to write inspection records, specifications and other reports. Familiarity with techniques for assuring data accuracy and integrity.
• Conducts problem identification analysis and corrective action investigations for internal operations. Supports problem identification analysis and corrective action for suppliers
• Represent the Quality Department on supplier improvement or supplier partnering programs.
• Represent the Quality Department on a process improvement team.
• Knowledge of sampling distributions, Binomial, Poisson, Normal and Exponential distributions and be able to apply statistical inference in each.
• Conducts Correlation and Regression Analysis, Experimental Design (DOE) and acceptance sampling; as well as conducting and interpreting Gage R&R studies.
• Analyzes data with statistical software and quality tools such as risk analysis, flow charts, control charts, scatter diagrams and histograms.
• Applies and incorporates risk management techniques throughout the product life cycle.
• Maintain general housekeeping of working area and plant.
• Builds stable working relationships internally.
• May refer to senior staff, if applicable, for assistance with day-to-day problems that may arise.
• Escalates issues to supervisor/manager for resolution, as deemed necessary.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist with various projects as assigned by direct supervisor.
• 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.

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