Senior Quality Assurance Engineer

<p>Vicarious Surgical is seeking a Senior Quality Assurance Engineer to join our team in Bangalore, India. This role will be tasked with supporting document and quality assurance activities equipment associated with our surgical robot.</p> <p>Vicarious Surgical is a US based next generation robotics company developing a disruptive technology with the goal of increasing the efficiency of surgical procedure, improving patient outcomes, and reducing healthcare costs.</p> <p>This is a terrific opportunity for an engineer to join our company at a very exciting time and be a key member of a team of mission-driven and kind individuals with diverse experiences to lead Vicarious into its next phase of market disruption. </p> <p>This individual will be employed by a Professional Employer Organization (PEO), but doing work specifically for Vicarious Surgical.</p> <p><strong>Working hours of Monday through Friday (Office hours start at 3PM to ensure significant overlap with US hours)</strong></p> <p> </p> <p><strong>Job Functions</strong></p> <p><strong>Management of the Vicarious Surgical Document Control and Training processes</strong>, ensuring compliance with FDA and ISO medical device regulations and Vicarious Surgical policies and procedures.</p> <p><strong>Create, review, modify, release, store and archive quality system documentation</strong>, procedures, specifications, and bills of materials (BOMs) utilizing change notices or requests within the product lifecycle management (PLM) system.</p> <p><strong>Update workflows, create forms and improve processes</strong>, including implementation of future software systems such as enterprise resource planning (ERP) as it pertains to the integration into our existing electronic PLM system.</p> <p><strong>Ensure quality records, including master hard copies, are maintained</strong> and oversee the employee training database to track requirements from notification through to completion.</p> <p><strong>Ensure document change request (DCR) training and implementation plans are complete</strong>, and notification of approved and closed DCR’s is communicated.</p> <p><strong>Provide quality monitoring data for trending metrics</strong> and compile critical information in response to audit, legal or research requests.</p> <p><strong>Interface well with management, Supply Chain, Advanced Manufacturing Engineering, R&D Engineering, and Project Management.</strong></p> <p><strong>Support Operations with equipment qualifications (IQ/OQ/PQ), risk analysis (PFMEA), process validations</strong>, and lead test method validations plans/protocols and reports.</p> <p><strong>Use various statistical techniques, including design of experiments (DOE)</strong>, and quality tools to analyze results.</p> <p><strong>Prepare nonconforming reports, assist in disposition decisions</strong>, and establish Quality Inspection Plans for components, assemblies, finished devices, and product/packaging labeling.</p> <p><strong>Support supplier selection, certification, and evaluations</strong>; lead supplier audits to resolve findings and/or nonconformances.</p> <p><strong>Perform internal audits as needed.</strong></p> <p><br><br></p> <p><strong>Requirements</strong> </p> <ul> <li>Minimum of a BS in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Process Engineering, or equivalent degree.</li> <li>5+ years as a Quality Engineer or similar in a related field or a combination of equivalent education and relevant experience.</li> <li>Minimum 2 years of experience with establishing, implementing and maintaining an electronic product data management system, electronic quality management system and/or product lifecycle management system, within the medical device industry </li> <li>Must have Working knowledge of defect avoidance methodologies such as poke yoke, DFMEA/PFMEA, DOE.</li> <li>Must have Knowledge of FDA 21CFR 820, 11 & ISO 13485 Quality System Regulations</li> <li>Working knowledge of device master records, BOM’s, and manufacturing resource planning systems</li> <li>Working knowledge of electrical and mechanical design drawings and file formats</li> <li>Coordination of employee training programs, preferably database driven</li> <li>Proficiency with Microsoft Office Suite, Adobe Acrobat, SolidWorks  </li> <li>Strong interpersonal, teamwork and decision-making skills</li> <li>Experience with root cause analysis tools and methods.</li> <li>Working knowledge of defect avoidance methodologies such as poke yoke, DFMEA/PFMEA, DOE.</li> </ul>