Senior Clinical QA & Audit Lead

Boston Scientific; Maple Grove (MN); Hybrid; USD 116,600 - 221,500; Full time

Job summary

Boston Scientific is seeking a Principal Clinical Quality Assurance Specialist to support the internal clinical QA program for the assigned business area. You will partner with cross‑functional teams to ensure investigations comply with regulatory requirements, GCP and company policies, serving as QA representative on clinical project teams and leading audits.

You’ll plan and conduct audits, assess regulatory compliance, and drive CAPA activities to sustain inspection readiness and data

Qualifications

• Bachelor's degree in science, engineering, health sciences or a related discipline.
• Minimum of 5 years' experience in Clinical Quality Assurance or a related quality function.
• Minimum of 5 years' experience conducting GCP audits or clinical research audits.
• Working knowledge of ISO 14155, ISO 13485, GCP, GMP and GDP.
• Experience supporting quality systems, CAPA and regulatory compliance activities.
• Ability to travel up to 30%.

Responsibilities

• Serve as the Clinical Quality Assurance representative on clinical project teams, promoting inspection readiness.
• Plan, schedule and conduct internal and external quality assurance audits of clinical systems, sites, processes and controls.
• Assess compliance with study protocols, GCP, regulatory requirements and Boston Scientific policies.
• Evaluate accuracy, integrity and quality of clinical data generated during clinical investigations.
• Communicate audit observations, evaluate responses, monitor corrective actions and ensure timely closure of audit findings.
• Support investigator sites during regulatory inspections, including preparation activities and responses to inspection findings.
• Contribute to the development and continuous improvement of Clinical QA processes, audit procedures and annual audit planning.
• Support clinical CAPA activities by partnering with CAPA owners and providing quality guidance.
• Represent Clinical Quality during acquisitions and integration activities, identifying risks and ensuring compliance with quality systems.
• Demonstrate a commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality System and participating in audits.

Skills

GCP audits

Quality Assurance

CAPA

Regulatory compliance

Audit planning

Cross-functional collaboration

Education

Bachelor's degree in science/engineering/health sciences

Job description

Boston Scientific is seeking a Principal Clinical Quality Assurance Specialist to support the internal clinical QA program for the assigned business area. You will partner with cross‑functional teams to ensure investigations comply with regulatory requirements, GCP and company policies, serving as QA representative on clinical project teams and leading audits.

You’ll plan and conduct audits, assess regulatory compliance, and drive CAPA activities to sustain inspection readiness and data