Quality Assurance Engineer

Job Description Summary

To develop and document Quality plans and procedures as required. Prevent and resolve Quality problems. Improve areas of high-quality costs. Represent quality interests and concerns on project teams. Conduct root cause analysis and investigation for customer complaints and non-conformance product. Ensure compliance with Corporate, ISO, FDA, and Local standards requirements.

Job Description

Job Responsibilities

• Provide technical support to resolve quality problems in development, pilot, manufacturing
• Design and conduct quality engineering studies to determine causes of quality nonconformances, initiate changes in process, tooling, etc., to correct them.
• Organize and generate detailed quality information reports to engineering, manufacturing, and management.
• Provide documented instructions for performance of QC inspections, including QC plans, inspection and test procedures, and quality Standards.
• Exercise control over the quality of conformance of the products generated in his areaDesign and qualify inspection and test equipment.
• Lead and guide peers and direct-reporting personnel, on how to conduct the Nonconformance process (NC).
• Development of Test Methods.
• Development of Control Plans.
• Approve/support validations protocols (Software/IQs/OPs/PQs) if applicable.

• Bachelor's degree in technical sciences or Engineering.

• Minimum 1year experience in Quality/Manufacturing or Engineering positions.
• Knowledge on International Regulations and Standards (i.e., ISO-13485, FDA, etc.).
• Knowledge on Quality Tools and statistical techniques. (Control charts, sampling plans, Design of experiments, etc.).
• Knowledge on Quality systems.
• Communication, Reports, Data analysis.
• Root cause analysis techniques.
• Ability to communicate in English (Oral and written) fluently.