Quality Engineer II

Fresenius Medical Care•Ogden, UT

17d

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 quality principles to support daily operations and continual improvement, and applies understanding of supplier products and processes to drive quality improvements and communicate them clearly to customers. The position investigates root causes and solutions for product release issues using nonconformance reports (NCR), corrective and preventive actions (CAPA), material containment and hold forms (MCH), and affected lot hold forms (ALH). It supports departments on product quality, inspections, deviations, and disposition of nonconforming product; analyzes data for process improvement; and recommends ways to prevent defects from recurring. Depending on the applicable department or location addendum, the role may also support engineering studies, qualification and validation, inspection and testing, environmental controls, equipment calibration, or injection molding process development. The position 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.

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 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), acceptance sampling, and conducting and interpreting Gage R&R studies.
Strong oral and written communication skills.
Strong computer skills and proficiency with Microsoft Office.

Nice To Haves

Injection molding experience preferred.
Process parameter development, scientific/decoupled molding, mold design, and RJG Master Molder experience are a plus.
Working knowledge of engineering and non-engineering polymers used in injection molding medical components, with polymer molding and processing experience, is preferred.
Experience with lean manufacturing philosophies, tools, and methods.

Responsibilities

Investigate root causes and solutions for product release issues through NCR, CAPA, MCH, and ALH processes.
Use quality improvement tools and techniques.
Support departments with product quality, inspections, deviations, and disposition of nonconforming product.
Recommend measures to prevent recurrence of defects to manufacturing, engineering, supply chain, and other departments.
Analyze reports and data to support in-house process improvements, corrections, and corrective actions.
Develop quality knowledge through training and ongoing assessment of relevant publications, standards, and regulations, including topics related to quality projects, material issues, and sterilization processes.
Assist junior-level staff with general tasks as directed by the immediate supervisor, and seek senior-level assistance with higher-level problems as needed.
Escalate issues to a supervisor or manager for resolution when necessary.
Assist with projects assigned by the direct supervisor and perform other duties as assigned.
For Engineering/Ogden: provide direction in establishing process improvement projects; perform engineering studies, feasibility reports, qualification and validation activities, data collection and analysis, and specification development; support implementation, teaching, and maintenance of lean principles; and apply statistical techniques, DOE, risk management, HACCP, FMEA, and Gage R&R studies.
For Engineering/Lake Forest: perform receiving and first article inspections as required; sample, test, and release raw materials and finished products; perform in-process testing; maintain environmental-control and equipment-calibration logs; and decontaminate and inspect returned equipment in bio-safety cabinets and clean rooms.
For Engineering/Molding: process and develop tests, analyze data, and make recommendations.