What are the responsibilities and job description for the Quality Engineer position at InspireMD?
Job Description
Job Description
Position Summary : The Quality Engineer will play a key role in maintaining and improving the quality management system (QMS) for our medical device products. You will be responsible for ensuring product compliance with FDA regulations, ISO 13485 standards, and other applicable regulatory requirements. The ideal candidate will have strong experience in the medical device industry and a solid understanding of quality control processes, inspections, and testing methods.
Essential Duties and Responsibilities : To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Support development, implementation and maintenance of the Quality Management System (QMS)
- Support internal and external audits to assess compliance and identify opportunities for improvement
- Support product development processes with quality planning and risk management strategies
- Conduct root cause analysis and implement corrective and preventative actions (CAPA)
- Perform product inspections, validation, and verification to ensure product quality
- Assist in the development and review of product documentation, including device master record (DMR), device history records (DHR), and technical files
- Provide support for product testing and qualification activities (e.g. design verification, validation, and stability testing)
- Work with suppliers and vendor to ensure the quality for raw materials and components
- Maintain records and reports of quality metrics, trends and performance for continuous improvement initiatives
Qualifications : To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Preferred Qualifications :
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
