Senior Quality Assurance - Chapel Hill, NC, United States - Cynet Systems Inc.

Description

Qualifications Skill/Job Requirements:
Minimum Bachelor's degree in engineering or equivalent experience. Advanced degree preferred.
Minimum 8 years of experience in Quality Engineering or related field.
Deep knowledge of ISO standards or 9001) and application
Medical device industry experience preferred.
Knowledge in Tissue Manufacturing preferred in addition to Knowledge of Human and Animal anatomy.
Prior experience with APHIS compliance and registration as well as USDA Regulations preferred.
Experience with diverse manufacturing processes e.g Manual assembly processes, synthetics, plastics molding, forming, assembly, etc.
Minimum 7 years of experience with validation, audits, CAPA.
Excellent Project management skills, problem solving skills, written and verbal communication.
Capable of thinking independently and making decisions based on limited information.
Knowledge of Lean/6 Sigma/Root Cause analysis, Black Belt level preferred
Computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP. Minitab is a plus.
Ability to read, interpret and communicate technical information.
Ability to travel on an as needed basis – domestic and international (up to 10%).