Design Quality Engineer

Job Role: Design Quality Engineer Location: Bedford, NH Provides direction and leadership for verification and validation of digital health technologies. Guide in establishing product and software requirements, specifications, detailed design, verification and validation protocols and planning documentation. Collaborate with project and program teams to ensure results comply with Client procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, EU Medical Device Directive (MDD)/ Medical Device Regulation (MDR), and applicable guidance. Provide Quality representation during problem resolution. Participate in technical design reviews and project phase reviews Utilize knowledge of risk management to ensure a risk-based approach for QMS processes. Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc. Please share your resume at chaitanya@starkassociatesllc.com (or) Contact: 848-277-1023