Principal Clinical Quality Assurance Specialist

Boston Scientific • Arden Hills, MN

5d

About The Position

Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated, documented and completed 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. 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%

Requirements

• 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%

Nice To Haves

• 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

Responsibilities

• Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated, documented and completed
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees