Quality Engineer II

Fresenius Medical Care•Ogden, UT

About The Position

The Quality Engineer II assists with disciplined problem solving for supplier, customer, and internal quality defects. The role maintains knowledge of products, processes, and basic quality principles to support daily operations and continual improvement, and applies technical understanding of supplier products and processes to drive quality improvements and communicate them clearly to customers. The position supports product quality investigations, process improvement projects, engineering studies, feasibility reports, qualification and validation activities, data collection and analysis, specification development, and implementation of lean principles. It uses quality and statistical techniques to investigate defects, prevent recurrence, and improve processes. Additional responsibilities may focus on one or more departments or locations, as described in an applicable addendum.

Requirements

Bachelor’s degree required.
2–5 years of related experience, an advanced degree without experience, or equivalent directly related work experience.
Strong analytical and troubleshooting skills.
Ability to understand and use 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, and governmental regulations.
Familiarity with correlation and regression analysis, Experimental Design (DOE), and acceptance sampling.
Ability to conduct and interpret gage R&R studies.
Strong oral and written communication skills.
Strong computer skills and proficiency with Microsoft Office.

Responsibilities

Investigate root causes and solutions for product release through nonconformance reports (NCR), corrective and preventive actions (CAPA), material containment and hold forms (MCH), and affected lot hold forms (ALH).
Support all departments regarding product quality, inspections, deviations, and disposition of non-conforming product.
Recommend measures to manufacturing, engineering, supply chain, and other departments to prevent recurrence of defects.
Analyze reports and data to support in-house process improvements, corrections, and corrective actions as part of continual improvement.
Build quality-related knowledge through training and continuous assessment of current publications, standards, and regulations, including knowledge related to quality projects, material issues, and sterilization processes.
Provide direction in establishing process improvement projects.
Conduct engineering studies, feasibility reports, qualification and validation activities, data collection and analysis, and specification development.
Assist the QE department and other departments in implementing, teaching, and maintaining lean principles.
Use 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.
As directed by the immediate supervisor, assist junior-level staff with general tasks requiring a better understanding of functions.
Refer higher-level problems to senior-level staff for assistance.
Escalate issues to a supervisor or manager for resolution as appropriate.
Assist with projects assigned by the direct supervisor and perform other duties as assigned.