Senior Quality Assurance Engineer

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.

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.

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.

This individual will be employed by a Professional Employer Organization (PEO), but doing work specifically for Vicarious Surgical.

Working hours of Monday through Friday (Office hours start at 3PM to ensure significant overlap with US hours)

Job Functions

Management of the Vicarious Surgical Document Control and Training processes, ensuring compliance with FDA and ISO medical device regulations and Vicarious Surgical policies and procedures.

Create, review, modify, release, store and archive quality system documentation, procedures, specifications, and bills of materials (BOMs) utilizing change notices or requests within the product lifecycle management (PLM) system.

Update workflows, create forms and improve processes, including implementation of future software systems such as enterprise resource planning (ERP) as it pertains to the integration into our existing electronic PLM system.

Ensure quality records, including master hard copies, are maintained and oversee the employee training database to track requirements from notification through to completion.

Ensure document change request (DCR) training and implementation plans are complete, and notification of approved and closed DCR’s is communicated.

Provide quality monitoring data for trending metrics and compile critical information in response to audit, legal or research requests.

Interface well with management, Supply Chain, Advanced Manufacturing Engineering, R&D Engineering, and Project Management.

Support Operations with equipment qualifications (IQ/OQ/PQ), risk analysis (PFMEA), process validations, and lead test method validations plans/protocols and reports.

Use various statistical techniques, including design of experiments (DOE), and quality tools to analyze results.

Prepare nonconforming reports, assist in disposition decisions, and establish Quality Inspection Plans for components, assemblies, finished devices, and product/packaging labeling.

Support supplier selection, certification, and evaluations; lead supplier audits to resolve findings and/or nonconformances.

Perform internal audits as needed.

Requirements

• Minimum of a BS in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Process Engineering, or equivalent degree.
• 5+ years as a Quality Engineer or similar in a related field or a combination of equivalent education and relevant experience.
• 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
• Must have Working knowledge of defect avoidance methodologies such as poke yoke, DFMEA/PFMEA, DOE.
• Must have Knowledge of FDA 21CFR 820, 11 & ISO 13485 Quality System Regulations
• Working knowledge of device master records, BOM’s, and manufacturing resource planning systems
• Working knowledge of electrical and mechanical design drawings and file formats
• Coordination of employee training programs, preferably database driven
• Proficiency with Microsoft Office Suite, Adobe Acrobat, SolidWorks
• Strong interpersonal, teamwork and decision-making skills
• Experience with root cause analysis tools and methods.
• Working knowledge of defect avoidance methodologies such as poke yoke, DFMEA/PFMEA, DOE.