Senior Clinical Quality Assurance Specialist

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.

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.

Work model, sponsorship:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

● 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.

Qualifications:

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.

Requisition ID: 630393

Minimum Salary: $ 81000

Maximum Salary: $ 153900

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).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.