Senior Clinical QA Auditor & Compliance Leader

Boston Scientific Gruppe; Marlborough (MA); Hybrid; USD 116,600 - 221,500; Full time

Job summary

Boston Scientific seeks a Principal Clinical Quality Assurance Specialist to lead QA activities within assigned business areas, ensuring compliance with GCP, ISO standards and Boston Scientific policies. You will conduct internal and external audits, support CAPA and inspection readiness, and collaborate with cross-functional teams across multiple sites.

The role requires at least 5 years in clinical quality assurance and the ability to travel up to 30%.

Qualifications

• Bachelor's degree in science, engineering, health sciences or related.
• Minimum 5 years in Clinical Quality Assurance or related quality function.
• Minimum 5 years' experience conducting GCP/clinical audits.
• Knowledge of ISO 14155, ISO 13485, GCP, GMP and GDP.
• Experience with quality systems, controlled processes and CAPA.

Responsibilities

• Represent Clinical QA on project teams and maintain inspection readiness.
• Plan, schedule, and conduct QA audits of clinical systems and sites.
• Assess compliance with study protocols, GCP, and regulatory requirements.
• Evaluate accuracy and quality of data from clinical investigations.
• Communicate audit findings and follow up on corrective actions.
• Support inspections and responses to findings during regulatory reviews.
• Contribute to QA process improvements and annual audit planning.
• Assist with acquisitions/integration by ensuring QA processes align.

Skills

GCP audits

Regulatory compliance

CAPA planning

Audit coordination

Cross-functional collaboration

Quality systems knowledge

Education

Bachelor's degree in science/engineering/health sciences

Job description

Boston Scientific seeks a Principal Clinical Quality Assurance Specialist to lead QA activities within assigned business areas, ensuring compliance with GCP, ISO standards and Boston Scientific policies. You will conduct internal and external audits, support CAPA and inspection readiness, and collaborate with cross-functional teams across multiple sites.

The role requires at least 5 years in clinical quality assurance and the ability to travel up to 30%.