Principal Clinical Quality Assurance Specialist

B Capital; Maple Grove (MN); Hybrid; USD 117,000 - 222,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Clinical Quality Assurance professional to act as QA representative on clinical project teams, promoting inspection readiness and overseeing audits of clinical systems, sites, and processes.

The role requires 5+ years in QA for clinical research, strong knowledge of GCP, ISO 14155/13485, GMP and GDP, and willingness to travel up to 30%. hybrid work model with location options in MA or MN.

Qualifications

• Bachelor's degree in science, engineering, health sciences or related discipline.
• Minimum of 5 years' experience in Clinical Quality Assurance or 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, GCP, GMP and GDP.
• Experience supporting quality systems, CAPA and regulatory compliance activities.
• Ability to travel up to 30%.

Responsibilities

• 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.

Skills

GCP audits

Quality systems

CAPA

Regulatory compliance

GMP/GDP

GCP

Travel ability

Education

Bachelor's degree in science/engineering/health sciences

Job description

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.

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.

#LI-Hybrid

Requisition ID: 631122

Minimum Salary: $ 116600

Maximum Salary: $ 221500

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.