Quality Engineer II

Purpose and Scope

Provide assistance in performing disciplined problem solving for supplier, customer, and internal quality defect. Maintains knowledge of all products, processes, and basic quality principles required to assist with daily operations and continual improvement activities.

Understands the technical aspects of the company including supplier products and processes in order to drive quality improvements and communicate them clearly to the customer. PRINCIPAL DUTIES AND RESPONSIBILITIES: 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.

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 responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS: The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Ability to lift up to 50 lbs. as required.

The employee may also be exposed to bovine and human blood products. Hepatitis B Vaccination is recommended EDUCATION: Bachelor's Degree required EXPERIENCE AND REQUIRED SKILLS: 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. ADDENDUM: Engineering/Ogden 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.

Engineering/Lake Forest Performs receiving Inspection and First Article Inspection processes as required. Performs sampling, testing and release procedures for raw materials and finished product. Performs in process testing during production as required. Performs environmental control of equipment and rooms and maintains appropriate logs. Performs equipment calibration as required and maintains appropriate logs.

Decontaminates and inspects equipment returned by end users in bio-safety cabinets and clean rooms. Engineering/Molding Capable of processing, developing tests, analyzing the data, and making recommendations. Preferred injection molding experience. Process parameter development, scientific/decoupled molding, mold design, RJG Master molder a plus.

Preferred working knowledge of polymers (engineering and non) used for injection molding of medical components with processing and engineering experience in polymer molding and processing. Experience with Lean manufacturing philosophies, tools, and methods.