Quality Engineer II

• ◆Investigates root cause solutions for product release through nonconformance reports (NCR), corrective and preventative actions (CAPA), material containment and hold forms (MCH) and affected lot hold forms (ALH).
• ◆Familiar with quality improvement tools and other various quality techniques.
• ◆Provides support to all departments regarding product quality, inspections, deviations and disposition of non-conforming product.
• ◆Recommends measures necessary to prevent a recurrence of defects to manufacturing, engineering, supply chain and other departments as needed.
• ◆Analyzes reports and data in support of in-house process improvements, corrections, and corrective actions as a means of continual improvement.
• ◆Self-motivated to improve knowledge related to quality projects, material issues, sterilization processes through training and continuous assessment of current publications, standards and regulations.
• ◆Provides direction in establishing process improvement projects. Responsible for engineering studies, feasibility reports, qualification and validation activities, data collection and analysis, and specification development.
• ◆Aids QE department and other departments as appropriate in the implementation, teaching, and maintenance of lean principles.
• ◆Utilizes basic statistical techniques, Experimental Design (DOE), Risk Management, Hazard Analysis and Critical Control Point (HACCP), and Failure Modes and Effects Analysis (FMEA). Conduct and interpret Gage Reproducibility and Repeatability (R&R) studies.
• ◆May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
• ◆May refer to senior level staff for assistance with higher level problems that may arise.
• ◆Escalates issues to supervisor/manager for resolution, as deemed necessary.
• ◆Assist with various projects as assigned by direct supervisor.
• ◆Other duties as assigned.

Additional

may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

• ✓2 – 5 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience.
• ✓Strong analytical & troubleshooting skills.
• ✓Ability to understand and employ mathematics at an engineering or scientific level.
• ✓Strong technical report writing skills.
• ✓Ability to read, analyze, and interpret common scientific and technical reports, technical procedures, or governmental regulations.
• ✓Familiarity with Correlation and regression Analysis, Experimental Design (DOE), and acceptance sampling; as well as conducting and interpreting gage R&R studies.
• ✓Strong oral and written communication skills.
• ✓Strong computer skills, proficient with Microsoft Office.

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