Boston Scientific · 4 hours ago
Principal Clinical Quality Assurance Specialist
Maple Grove, MN
Full-time
Hybrid
Senior Level, Lead/Staff
$102K/yr - $194K/yr
5+ years expBoston Scientific is a leader in medical science committed to solving important health industry challenges. The Principal Clinical Quality Assurance Specialist will serve as a subject matter expert in clinical vendor management, ensuring quality and compliance of clinical service providers and supporting global clinical audit programs.
Health CareMedicalMedical Device
No H1B
Responsibilities
Assess potential new vendors providing clinical services to ensure their capabilities meet quality and compliance expectations
Participate in or lead vendor audits to determine qualification status and compliance with GCP and regulatory requirements
Prepare, maintain, and manage the global Clinical Approved Vendor List (cAVL) for PQS
Write and revise vendor management procedures in collaboration with Clinical functional teams, Sourcing, and Clinical Supply Chain
Support regulatory inspection readiness by ensuring documentation and vendor assessments are complete and audit-ready
Investigate clinical vendor quality issues and assist in developing or reviewing corrective action plans
Review or audit study and validation activities and associated documentation for protocol, SOP, and GCP compliance
Issue audit certificates when appropriate and document findings through audit reports
Track audit findings and corrective actions to completion, maintaining full documentation in audit systems or databases
Contribute to or lead departmental SOP and work instruction development
Support or lead cross-functional projects to enhance clinical vendor oversight and compliance
Qualification
Required
Minimum of a bachelor's degree, or an associate degree with a minimum of 7 years' professional experience
Minimum of 5 years' auditing experience in a regulated industry
Experience working in FDA-regulated environments such as medical devices, pharmaceuticals, or biologics
Experience in Clinical Quality Assurance or other Clinical or Quality-related roles
Willingness and ability to travel up to 25–30% domestically and internationally, as needed
Preferred
Bachelor's degree with a minimum of 7 years' professional experience conducting vendor audits
Experience working in vendor quality roles across multiple sectors (e.g., pharmaceuticals, biologics, medical devices)
Direct experience with Clinical Quality, including oversight of CROs and other clinical service providers
Prior experience working with Boston Scientific's vendor management systems and processes
Benefits
Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
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