Quality Assurance II

Fresenius Medical Care•Ogden, UT

About The Position

The Quality Assurance II role assists with disciplined problem solving for supplier, customer, and internal quality defects. The employee maintains knowledge of products, processes, and quality principles to support daily operations and continual improvement, and understands supplier products and processes to drive quality improvements and communicate them clearly to customers. The position supports product quality, inspections, deviations, and disposition of non-conforming product across departments. It contributes to process improvement projects, engineering studies, feasibility reports, qualification and validation activities, data collection and analysis, and specification development. It also supports implementation and maintenance of lean principles and may assist junior staff with general tasks as directed. The role requires a bachelor’s degree and 2–5 years of related experience, an advanced degree without experience, or equivalent directly related work experience. The employee may need to lift up to 50 pounds and may be exposed to bovine and human blood products; Hepatitis B vaccination is recommended. Fresenius Medical Care maintains a drug-free workplace and is an equal opportunity employer.

Requirements

Bachelor’s degree required.
2–5 years of related experience; alternatively, an advanced degree without experience or equivalent directly related work experience.
Strong analytical and troubleshooting skills.
Ability to understand and apply mathematics at an engineering or scientific level.
Strong technical report-writing skills.
Ability to read, analyze, and interpret 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.
Ability to lift up to 50 pounds as required.

Nice To Haves

Hepatitis B vaccination is recommended.

Responsibilities

Investigate root causes and solutions for product release issues through nonconformance reports (NCR), corrective and preventative actions (CAPA), material containment and hold forms (MCH), and affected lot hold forms (ALH).
Use quality improvement tools and other quality techniques.
Support 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, corrective actions, and continual improvement.
Develop quality-project knowledge related to material issues and sterilization processes through training and ongoing review of publications, standards, and regulations.
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.
Assist junior-level staff with general tasks as directed by the immediate supervisor.
Refer higher-level problems to senior staff for assistance as needed.
Escalate issues to a supervisor or manager for resolution as necessary.
Assist with projects assigned by the direct supervisor and perform other duties as assigned.