Job Description:
We are seeking a highly skilled Quality Engineer to join our team. As a medical device company, we strive to make a tangible impact on people's lives.
The ideal candidate will have a solid understanding of quality assurance principles and practices, with experience in monitoring, controlling, and improving customer processes.
This role involves working closely with internal customers and regulatory agencies to ensure compliance with FDA's Quality System Regulations, ISO 9000, and other international standards.
The successful candidate will be responsible for managing closed-loop customer complaints, generating and reviewing quality metrics systems, and overseeing DMR/DHR and Technical Files.
Key Responsibilities:
* Management of customer complaints and improvement processes
* 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