Quality Assurance Engineer

Job Summary

Support the maintenance of the Quality Management System for compliance to ISO 13485 and appropriate regulatory bodies and customer agreements. Define requirements for new products, monitoring production quality performance to identify opportunities for improvement and support maintenance of quality files, procedures, and work instructions for proper adherence to the quality system.

Essential Duties & Responsibilities

1. Evaluate specification, requirements, and design documents to provide prompt and valuable feedback to internal and external customers.
2. Develop detailed and well-structure validation plans using IQ OQ PQ structure.
3. Estimate, prioritize, plan and coordinate validation activities to ensure conformance to regulations, internal requirements and customer requirements.
4. Ensure all validation documentation completed per requirements.
5. Develop and execute FMEAs and risk assessments with internal and external teams as needed.
6. Support investigation of root cause of non-conformances and corrective actions.
7. Use quality tools to analyze and identify areas for improvements and problem solving techniques.
8. Support new product development and production to ensure that the product meets customer expectations.

Competencies

• Manufacturing Safety
• College Degree or 4+ years QE experience
• Quality Tools and Data Analysis