Senior Clinical Quality Assurance Specialist

Senior Clinical Quality Assurance Specialist Location: Marlborough, MA 01752 Additional Locations: US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove Hybrid work model: at least 3 days per week in the local office. This role does not sponsor or take over employment visa sponsorship. About the Role The Senior Clinical Quality Assurance Specialist assists the Manager, Clinical QA in maintaining the internal quality assurance program for the assigned business area. The specialist serves as the Clinical QA representative on clinical project teams, conducts internal and external quality audits, supports inspection readiness, Clinical Corrective and Preventive Action (CAPA) activities, and acquisition integration initiatives. Responsibilities Participate on clinical project teams and influence teams toward a continuous state of inspection readiness. Plan, schedule and conduct internal and external quality assurance audits of systems, clinical investigative sites, procedures and controls employed in the design, conduct and analysis of clinical trials. Assess sponsor, investigator and monitor compliance with study protocols, Good Clinical Practice (GCP), applicable regulatory requirements and Boston Scientific policies and procedures. Assess the accuracy, validity and quality of scientific data generated during clinical trials. Participate in problem‑solving activities with project teams and investigator sites. Communicate audit observations to clinical investigators and clinical program managers. Document audit observations, evaluate the impact of audit findings, assess responses and ensure appropriate corrective actions are completed. Ensure audit findings are appropriately tracked through closure. Contribute to the development of audit procedures and processes. Assist Clinical QA managers with annual audit planning, review and trending of audit results and implementation of continuous improvement initiatives. Assist in preparing investigator sites for FDA and other regulatory agency inspections, including support for written responses to inspection findings. Stay current on worldwide regulatory requirements and advise management on the potential impact of regulatory changes. Support the Clinical organization in meeting Boston Scientific Quality System requirements. Support the CAPA process by partnering with Clinical NCEP/CAPA owners and providing quality assurance expertise. Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality Policy and all documented quality processes and procedures. Ensure appropriate resources are maintained to support Quality System compliance. Promote a work environment that supports the Boston Scientific Quality Policy and Quality System. Required Qualifications Bachelor’s degree in science, health, engineering or a related field of expertise. Minimum of 3 years’ experience with quality systems and controlled processes. Ability to travel up to 30%. Preferred Qualifications Working knowledge of ISO 14155 and Good Clinical Practice (GCP). Auditing experience in the medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines, or equivalent relevant experience. Working knowledge of U.S. and international regulations and standards applicable to Boston Scientific. Additional quality certifications, such as ASQ, SOCRA, RQAP-GCP or equivalent. Experience working cross‑functionally with multiple stakeholders. Compensation Minimum salary: $81,000. Maximum salary: $153,900. Equal Employment Opportunity Statement Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Legal Requirements Prohibited substance testing is required for this safety‑sensitive position. Candidates will be subject to a prohibited substance test as a requirement to increase workplace safety in compliance with applicable law. Nearest Major Market Boston #J-18808-Ljbffr Boston Scientific Gruppe