Quality Engineer

We have a client located in Latrobe PA seeking a Quality Engineer

Job Duties:

- Evaluate requirements & design documents to provide prompt feedback to customers
- Develop validation plans using IQ OQ PQ Structure
- Plan validation activities to ensure compliance to regulations, internal requirements, & customer requirements
- Ensure all validation documentation is completed
- Develop and execute FEMAs risk and assessments with internal & external teams
- Use quality tools analyze and id areas for improvement and problem solving techniques
- Support new product development and production




Requirements:

- 4 years of QE Experience
- Extensive Injection Molding Experience
- Previous Medical Industry experience preferred
- Experience with ISO 13485 preferred
- SPC software experience and strong data analysis required





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