Identify, lead, and complete Packaging Quality and Continuous improvement projects and objectives through successful implementation.
Utilizes compliance and notification trends to identify areas of manufacturing improvement using product knowledge, existing specifications, and engineering principles.
Develops and employs technical understanding of product characteristics and functional end-use in order to effectively investigate complaint trends or other targeted product functionality improvements.
Utilizes accepted site problem solving processes and documents activities through official channels in a manner presentable to inspectors
Effectively communicates progress and outcomes of problem solving activities and implementation of corrective and preventative actions.
Creates or modifies plant control plans with process remediation activities.
Leads or participates on cross-functional process remediation and improvement teams as assigned by local quality management.
Independently identifies process improvement opportunities and ensures that items have been presented to leadership for prioritization.
Independently reacts to quality trends and develops designed experiments and project plans to remediate them Indirectly oversees and drives cross functional teams to complete projects.
EDUCATION, EXPERIENCE AND SKILLS REQUIRED
A B.S. Degree in Engineering, Science or a related field, is required.
Experience in medical device manufacturing is required.
A working knowledge of process validation, Six Sigma, SPC, GMP and quality theories is strongly preferred.
A strong understanding of statistics and designed experiments using scientific method is required.