Compliance Specialist III

Compliance Specialist IIICompliance Specialist III performs the day-to-day administration of all processes related to internal and external audit. This role ensures that all Quality audit activities are being performed per Intuitive Surgical released procedures.Manage external audit administration activities, including coordination, logistics, and preparation for external auditsMonitor the audit finding related activities as a result of internal and external audits to ensure timely completionDevelop and facilitate the reporting of external and internal audit related metrics to ensure compliance to internal procedure and external commitmentsExecute the governance process to ensure timely and effective reviews of audit findings and visibility to Senior ManagementPromote a culture of compliance to regulations, standards, and procedures and risk management through monitoring and reporting processServe as key liaison for engineering change orders/QMS project supportLead and refine the internal audit module, including troubleshooting issues as needed and knowing when to escalate to IT, partnering with Training LMS Administrator to develop, improve, and administer Audit Module training, provide group or individual training, ensure process changes per documented procedures in Audit ModuleMonitor and audit adherence to corporate policies as directed and investigate any violations, including coordinating investigations, audits, conducting interviews, and preparing reportsLead other audit management related projects as requiredMinimum Bachelor's Degree or equivalent years of experience, in Engineering, physical or biological science or other technical fieldA minimum of 2-3 years of experience in compliance role in the medical device industryA working knowledge of project management tools and techniquesKnowledge of EU-MDR, ISO 13485:2016; Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, Health Canada, and other international regulatory requirementsCertified Quality Auditor/ISO lead Auditor Certification desiredDemonstrated ability to effectively work with cross-functional/cross-plant project teams and work effectively with a variety of work groupsExperience interpreting, and providing guidance on domestic and international regulations as applicable to the quality management systemStrong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environmentStrong interpersonal skills - ability to work closely with people at all levels within the organization and facilitate the implementation of corrective action