Senior Quality Assurance Engineer
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 (13485 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%).
Estimated Salary: $20 to $28 per hour based on qualifications.
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