Quality Engineer II

Work on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Participate in decisions on scope of work, selection of equipment and length of tasks. Must be able to accomplish broad and complex assignments. May provide technical guidance to lower level personnel.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.

• Independently performs most assignments with instructions as to the general results expected.

• Represent Quality Assurance for Non-Conformance Report dispositions, and coordinate monthly Oversight Review Board presentation as needed.

• Support Value Stream in daily activities

• Participate in process and product quality/cost improvement projects

• Investigate and manage customer field Complaints, SCAR's and internal CAPA's as needed.

• Diagnose and resolve manufacturing and quality system issues

• Revise and provide training to manufacturing documents and other quality-related topics

• Interface with customers and suppliers as needed for quality issues and project requirements and change requests

• Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.

• Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance interval analysis, ANOVA.

• Support Hosting of External Customer and or Notified Body Audits as applicable.

• Create and/or approve validation protocols and reports and other technical documents

• Completed basic production, health, safety and environmental hazard communication training.

• Follows all safety and production standard operating procedures.

• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.

EDUCATION and/or EXPERIENCE:

• BS in a related engineering discipline; and 5 + years of related experience or equivalent combination of education and experience.

• Understanding of statistical data analysis using Minitab

• Must possess more than a basic understanding of engineering theoretical fundamentals and experimental techniques.

• Good written and oral English communication skills. Computer literate

• Understanding of in various tools within Excel

• Experience in the medical device industry and/or manufacturing a plus

• ASQ Certified Quality Engineer would be an asset

COMMENTS: This job description is an outline of the major recurring responsibilities of the job. It is not intended to be all inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent(s).