In this role, you will have the opportunity to assure Vicarious Surgical, Inc.’s quality system complies to various regulatory and standards applicable for design, development, manufacturing, distribution and field support of medical devices. In addition, be a key contributor to future process and system development efforts within the quality organization. The ideal candidate is a self-starter with experience in a startup environment.
Developing programs, workflows, and standard operating procedures for the Internal Audit program.
Perform internal audits as an Auditor and/or Lead Auditor per the established audit scope and objectives.
Planning, coordinating, and executing internal QMS and/or product-focused audits to assess the compliance and effectiveness of the overall QMS of the organization under audit.
Reviewing responses to audit findings for completeness and effectiveness.
Reporting monthly internal audit finding and completion progress.
Participating in Quality & Regulatory initiatives as a cross-functional contributor.
Supporting external audits as needed.
Monitor implementation and continuous improvement efforts of the quality system, ensuring compliance to SOP’s and identifying areas for improvement.
Supporting other Quality & Regulatory initiatives as needed.
Bachelor’s degree, or equivalent experience.
3+ years’ experience in a regulated industry (medical device, IVD, biologics or Pharma), medical device preferred.
Current certification with a recognized accreditation body (i.e., RAB-QSA/IRCA (Exemplar Global)); OR ASQ certification as a Certified Quality Auditor (CQA); OR successful completion of a Lead Auditor Course from a reputable organization.
Working knowledge of global governing regulation, requirements and standards such as; 21 CFR Parts 803, 806, 820, 11; ISO 13485:2016, ISO 14971, European Medical Devices Regulations (2017/745), Canadian Medical Devices Regulations (SOR/98-282), and Japanese MHLW Ordinance 169.
Strong CAPA knowledge and experience.
Able to interact with varying levels of the organization.