Job Description Summary

Pursues and coordinates continuous process/product improvement opportunities by utilizing sound quality principles. Will interact with internal business process areas, multiple BD plants, Unit and Corporate with emphasis on Quality Improvement programs. Facilitates Quality Assurance (QA) in-process product release activities.

Job Description

The essential functions of this position include, but are not limited to:

• Plans and directs the work assignments and activities of QA personnel on four (4) shifts.  Assigns associates to specific projects.
• Oversees finished product inspection, testing, product transfer, product release and maintenance of product and process documentation.
• Supervises, trains and evaluates QA personnel in job performance and general QA skills. 
• Communicates with Production Facilitators to review process quality issues.
• Maintains quality trending, including Right the First Time metric.
• Formulates, reviews and implements policies and procedures relating to product quality and process control.
• Assures QA testing equipment is maintained in proper operating condition and current calibration.
• Supports and/or leads projects using continuous improvement tools and methodologies, including Six Sigma and Lean.
• Utilizes appropriate statistical and analytical techniques, such as the application of Failure Mode Effects Analysis (FMEA), hypothesis testing and Design of Experiment (DOE).
• Coordinates Measurement System Analysis (MSA) studies, process capability studies and process validations, analyzes data and submits recommendations.
• Maintains familiarity with manufacturing processes and products to evaluate cause/effect relationships.
• Acts as a resource to work groups and project teams, within and outside the Plant, to maintain the highest quality standards.
• Executes and advises others on validations.
• Assists in the design and implementation of statistical process control for Plant processes.
• Communicates with Production Facilitators to review process quality issues.
• Performs other duties, as assigned, including, but not limited to, internal audits and Product Incident Report (PIR) investigations.
• Supports Plant safety initiatives.
• Ensures that all activities comply with government (OSHA, EPA, FDA, ISO, etc.) regulations and corresponding Company policies/procedures, including activities and programs as defined in the Quality Systems Manual.

EDUCATION, EXPERIENCE AND SKILLS REQUIRED

Education

A B.S. or B.A. Degree from an accredited institution in science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent.

Knowledge of science, and statistical methods desirable, but not required.

Experience

Knowledge of inspection methods and procedures desired.

Prior supervisory experience desired.

Proven track record of supporting and driving continuous improvement activities in a production environment desired.

Black Belt / Six Sigma training desired.

Working knowledge of validations (IQ, OQ, PQ) and DOE’s desired.

Working knowledge and application of QSR’s/ISO 13485 desired.

Experience in application of FMEA and risk mitigation desired.

Experience with Value Stream Analysis and Lean methodology desired.

Physical RequirementsLevel 2

Light Work:  Exerting up to 20 pound occasionally, and/or 10 pounds of force frequently, or negligible constantly.  Walking or standing to a significant degree, or sitting constantly and pushing/pulling controls.

Mental Requirements

Strong verbal, written, analytical, persuasion and interpersonal skills required.

Equipment Use

Ability to use a personal computer, statistical software, measuring equipment and office equipment required.

Working Conditions

The position is subject to inside environmental conditions typically associated with an office environment and occasional exposure to extreme heat.

Primary Work Location

USA NE - Broken Bow

Additional Locations

Work Shift

US BD 1st Shift 7am-330pm (United States of America)