Senior Clinical Quality Assurance Specialist

Boston Scientific • Maple Grove, MN

2d • $81,000 - $153,900 • Hybrid

About The Position

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. The Senior Clinical Quality Assurance Specialist assists the Manager, Clinical QA, in maintaining the internal quality assurance program for the assigned business area. This role serves as the Clinical QA representative on clinical project teams and conducts internal and external quality audits to ensure Boston Scientific clinical investigations comply with applicable regulatory requirements and company policies and procedures. The Senior Clinical Quality Assurance Specialist also supports inspection readiness, Clinical Corrective and Preventive Action (CAPA) activities and acquisition integration initiatives.

Requirements

• 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%.

Nice To Haves

• 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.

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.

Benefits

• The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
• Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
• At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
• Compensation for non-exempt (hourly), non-sales roles 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior