Job Summary:
We seek a seasoned Quality Engineer to lead quality initiatives and ensure compliance with regulatory requirements. This role demands a deep understanding of quality assurance principles, with a focus on process improvement and customer satisfaction.
The successful candidate will be responsible for developing and implementing quality metrics systems, managing customer complaints, and leading audits to ensure conformance and effectiveness of the Quality System.
Key Responsibilities:
* Development and implementation of quality metrics systems
* Management of customer complaints
* Leading audits to ensure Quality System conformance and effectiveness
* DMR/DHR and Technical Files management
* Data collection, analysis, and reporting
* Pareto and trend analysis
* Initiation and driving of Continuous Improvement programs
* NPI Approval including First Article Inspections and Reporting
* CAPA, NCM, and RMA analysis and Improvement
* QSR Validation protocols and report (IQ, OQ & PQ)
Requirements:
* University Degree in Science or Engineering
* At least 2 years of Quality Assurance experience in a similar Quality Engineering role
* Solid understanding and utilization of Problem Solving Techniques
* Proficient in Microsoft Word, PowerPoint, and Excel
* Good communications and influencing skills
* Ability to respond to common inquiries or complaints from internal customers and regulatory agencies
* Ability to write standard operating procedures, training documents, and regulatory responses