Boston Scientific · 3 hours ago
Principal Clinical Quality Assurance Specialist
Maple Grove, MN
Full-time
Hybrid
Senior Level, Lead/Staff
$102K/yr - $194K/yr
8+ years expBoston Scientific is seeking a qualified Principal Clinical Quality Assurance Specialist to oversee and support clinical research quality with a focus on Good Clinical Practice (GCP). The role involves acting as an independent auditor and quality partner to clinical teams, ensuring compliance with regulatory expectations and internal procedures.
Health CareMedicalMedical Device
Responsibilities
Provides clinical quality representation on clinical trial project teams to always foster and inspire clinical teams towards a state of inspection readiness
Provides support and response to clinical quality, compliance and regulation questions including quality review of clinical study documents and related functional study plans
Owns and/or supports management of internal clinical, external investigator site and clinical supplier nonconforming event management and CAPAs
Supports Clinical Inspection Readiness program to include inspection readiness training and coordination, and participation in internal Mock BIMO inspections as well as external audits/inspections
Communicates with internal stakeholders regarding clinical vendors, new clinical vendor requests, current clinical vendor needs, and future needs
Creates risk-based study audit plans; plans, schedules, conducts, provides internal oral debriefs and writes formal audit reports to internal stakeholders and leadership for internal clinical quality audits, clinical process audits, investigator site audits, and clinical vendor audits to assure BSC clinical investigational pre-market, post-market and post approval clinical studies comply with applicable regulatory requirements, quality and GCP standards, and BSC policies and procedures
Documents evidence and provides rational and authoritative citations for audit observations of nonconformance; communicates audit observations; evaluates impact and makes recommendations for corrections and/or corrective actions. Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated, documented and completed
Keeps abreast of and interprets current worldwide regulatory requirements and good clinical practice standards; advises various stakeholders regarding possible ramifications of regulatory changes
Demonstrate an unwavering commitment to patient safety and clinical quality by adhering to the Quality Policy and all documented processes and procedures, and maintaining a patient centric quality focus
Supports Clinical and QS team during External Regulatory/Notified Body audits/inspections
Supports the CAPA program, providing quality input for assessing internal noncompliance and recommending initiation of corrections/CAPAs, working closely with Clinical CAPA team and CAPA owners through to successful closure
Participates in clinical process improvement projects and initiatives
Provides reviews and comments in relevant BSC procedure revisions
Supports departmental, divisional, and corporate quality goals and priorities
Initiates and/or collaborates on continuous improvement projects related to the BSC Clinical Quality Management System
Represents Clinical Quality on clinical acquisition/integration teams for identification, assessment, and mitigation of risks associated with the transfer of sponsorship of clinical studies from acquired entities, supporting development and execution of a clinical integration plan, transfer of quality systems, and compliance to GCP and applicable regulations with aim to ensure subject safety and integrity of study data
Qualification
Required
Minimum of a bachelor's degree in Science, Health, Engineering, or a related field with minimum of 8 years' experience in the medical device, pharmaceutical, or other industry in an area regulated by GCP regulations and guidelines; OR in the alternative, a life science or Nursing Associate Degree with active Registered Nurse licensure and at least 10 years of relevant clinical research experience
Demonstrated clinical research audit, compliance and related writing experience with one or more of the following: clinical trial primary research coordinator or monitor, GCP auditor, CAPA leader, research compliance auditor, clinical research SOP author, or equally relevant role
Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance
Working knowledge of regulations, standards, paper and electronic Good Documentation Practices, and privacy/security obligations relevant to conducting IDE Trials, including 21 CFR (50, 54, 56, 812, Part 11), GCP (ISO14155 and/or ICH E6), HIPAA and GDPR
Independent, reliable, professional, collaborative, team player aligned with BSC mission, vision, and culture goals
Demonstrated experience and critical thinking with complex verbal and written communication to a variety of stakeholders, as well as successful conflict resolution skills and strong presentation skills
Strong electronic system adopter/user with understanding of system user access controls and workflow validations process
Proficiency in MS Office apps WORD, Outlook, TEAMS, Excel, PowerPoint, SharePoint
Ability to travel domestically and internationally up to 30%
Preferred
RAQP-GCP/ SoCRA, CCRP, CHRC, or ACRP certification or equivalent
Experience with maintaining compliance with medical device manufacturer quality system or other clinical quality system requirements
US FDA, EU CA, Health Canada, PMDA, CFDA experience regarding clinical research, submissions and inspections
5 or more years of direct clinical quality (GCP) auditing experience
Knowledge of EU MDR pertaining to clinical investigations of medical devices
Demonstrated experience communicating with all levels of a complex organization
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
H1B Sponsorship
Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
Company data provided by crunchbase