Clinical Quality Assurance Specialist

Principal Clinical Quality Assurance SpecialistWork mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.About the role: Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. As a Principal Clinical Quality Assurance Specialist, you will support the internal clinical quality assurance program for your assigned business area, partnering with cross-functional teams to ensure clinical investigations comply with applicable regulatory requirements, Good Clinical Practice (GCP) and Boston Scientific policies and procedures. In this role, you will serve as the Clinical Quality Assurance representative on clinical project teams, conduct internal and external quality audits, and support inspection readiness, corrective and preventive action (CAPA) activities, and clinical acquisition integrations.Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to work from one of our local offices at least three days per week. This position may be based in Marlborough, Massachusetts; Arden Hills, Minnesota; or Maple Grove, Minnesota. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities will include:Serve as the Clinical Quality Assurance representative on clinical project teams, promoting a continuous state of inspection readiness.Plan, schedule and conduct internal and external quality assurance audits of clinical systems, investigative sites, processes and controls supporting clinical trials.Assess compliance with study protocols, GCP, applicable regulatory requirements and Boston Scientific policies and procedures.Evaluate the 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 by identifying risks, supporting sponsorship transfers and ensuring compliance with quality systems and regulatory requirements.Demonstrate a commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality System and participating in internal quality and supplier audits.Qualifications: Required qualifications: Bachelor's degree in science, engineering, health sciences or a related discipline. Minimum of 5 years' experience in Clinical Quality Assurance, clinical research compliance or a related quality function. Minimum of 5 years' experience conducting GCP audits, clinical research audits or other regulated quality audits. Working knowledge of ISO 14155, ISO 13485, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP). Experience supporting quality systems, controlled processes, CAPA and regulatory compliance activities. Ability to travel up to 30%. Preferred qualifications: Working knowledge of U.S. and international regulations and standards applicable to clinical research. Professional quality certifications, such as ASQ, SOCRA, RQAP-GCP or Certified Lead Internal Auditor. Experience collaborating with cross-functional stakeholders in support of clinical quality initiatives, inspections or acquisitions. Advanced degree in a scientific, engineering or health-related discipline.