✦ Luna Orbit — QA & Testing

Clinical Software Audit Manager

at Boston Scientific

📍 Arden Hills, MN, US, 55112 Hybrid Posted March 13, 2026
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Position Details

Type Full-Time
Experience mid
Exp. Years 7+ years
Education Not specified
Category QA & Testing

About this role

This role involves overseeing the audit and qualification of clinical and software vendors to ensure compliance with regulatory standards and internal quality policies.

Key Responsibilities

  • Lead vendor audits
  • Manage audit lifecycle
  • Ensure regulatory compliance
  • Develop audit tools
  • Mentor audit team

Technical Overview

Focuses on vendor audits, risk management, regulatory standards such as FDA, ISO 13485, IEC 60601, and ISO 14155, with expertise in audit tools, checklists, and electronic records management.

Ideal Candidate

The ideal candidate is an experienced clinical and software vendor audit manager with 7+ years in medical device quality assurance, familiar with international regulatory standards and risk management. They excel in leading audit teams and implementing continuous improvement initiatives.

Must-Have Skills

Experience leading clinical and software vendor auditsKnowledge of FDAISO 13485IEC 60601ISO 1415521 CFR Part 11Risk management expertiseTeam leadership and mentoring

Nice-to-Have Skills

Experience with audit tools and checklistsKnowledge of electronic records and signaturesIT security practices

Tools & Platforms

Audit ToolsChecklistsMetrics TrackingVendor Management Systems

Required Skills

Vendor AuditRegulatory ComplianceFDAISO 13485IEC 60601ISO 1415521 CFR Part 11Risk ManagementCorrective ActionAudit ToolsChecklistsMetricsVendor QualificationVendor CategorizationChange ManagementElectronic Records and SignaturesIT Security

Hard Skills

Vendor AuditRegulatory ComplianceFDAISO 13485IEC 60601ISO 1415521 CFR Part 11Risk ManagementCorrective ActionAudit ToolsChecklistsMetricsVendor QualificationVendor CategorizationVendor Control DocumentationChange ManagementElectronic Records and SignaturesIT Security

Soft Skills

LeadershipMentoringCollaborationCommunicationContinuous ImprovementProblem-solving

Industry & Role

Industry Healthcare & Medical
Job Function Vendor and Clinical Software Vendor Auditing in Medical Devices

Keywords for Your Resume

Vendor AuditRegulatory ComplianceFDAISO 13485IEC 60601ISO 1415521 CFR Part 11Risk ManagementCorrective ActionAudit ToolsChecklistsMetricsVendor QualificationVendor CategorizationChange ManagementElectronic Records and SignaturesIT Security

Deal Breakers

Lack of experience in vendor audits, No knowledge of FDA or ISO standards, Inability to lead or mentor teams

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