BrainRobotics is looking for an experienced quality technician to help develop and grow the company's product quality and processes. The role involves working with various departments to maintain and improve product quality and ensure compliance with industry standards and regulations. The daily work will require both QA and QC functions and may include direct work with product.
Key Responsibilities:
Develop, implement and maintain Quality system documentation. Update and maintain OP's and SOP's in conjunction with department headsManage CAPA Reports and Root cause analysis. Monitor CAPA actions, follow ups and reportingTest products and services including a variety of tasks involved from Incoming, MRB to final release and DHR Review.Manage documentation and reporting including A variety of tasks from ECO/ECN/DCO operations and approvals, as well as monthly, quarterly and annual reports (CAPA, Supplier, NCR ect) Assist and perform internal and supplier management and audits Assist in producing documentation for MDR and other international regulatory agenciesQualifications:
Bachelor's degree, CQE or equivalent experience in Quality, Engineering, or a related fieldRelevant work experience in Med tech Class 1 or Class 2 is required, with a focus on hardware and ISO 14385 and MDRA quick decision maker with great teamwork skills and detail-oriented personnelHands-on experience with hardware, hardware engineering, parts, drawings.Able to use standard office environment software and demonstrated proficiency in XLS. Ability to prioritize and respond to changing needs and demands. Excellent analytical and presentation skills is preferred
