Job Description:
We are looking for an experienced Quality Engineer to drive quality excellence in our organization. With a strong background in quality assurance, this individual will play a key role in ensuring customer satisfaction by monitoring, controlling, and improving all related customer processes.
This role requires a high level of collaboration with internal customers and regulatory agencies to guarantee compliance with relevant regulations and standards.
The successful candidate will be responsible for identifying, planning, and organizing regulatory affairs to ensure adherence to FDA's Quality System Regulations, ISO 9000, and other international standards.
Key Responsibilities:
* Monitoring and control of customer processes
* Regulatory affairs planning and organization
* Quality metrics system generation and review
* 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)
* Audits to ensure conformance and effectiveness of the Quality System
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