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Principal Clinical Quality Assurance Specialist Job

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Date: Nov 23, 2021

Location: Arden Hills, MN, United States, 55112

Company: Boston Scientific

Additional Locations:


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.

*This job will require 30-50% travel and can be based remotely


About the role:

The Clinical Quality Assurance Principal position assists  with internal quality assurance program for the assigned business area.  Serves as clinical QA representative on clinical project teams and conducts internal and external quality audits to assure that BSC clinical trials comply with all applicable regulatory requirements and BSC policies and procedures. The Clinical Quality Assurance Principal will support Inspection Readiness, Clinical Corrective and Preventative Action (CAPA) and acquisition integration.


Your responsibilities include:

  • Supports clinical project teams and influences them toward a state of inspection readiness at all times.
  • Conducts internal and external quality assurance audits of systems, clinical investigative site, procedures, and controls employed in the conduct of clinical trials.
  • Assesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures.
  • Assesses the accuracy, validity, and quality of the clinical trial data.
  • Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed.
  • Contributes to the development of audit procedures and processes.
  • Supports the preparation, coordination, and management of regulatory agency sponsor inspections of BSC offices.
  • Assists in preparation of investigator sites for FDA or other regulatory agency inspections.
  • Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
  • Support to the Clinical organization in meeting BSC Quality system requirements.
  • Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners.
  • Supports clinical integration teams of acquisitions to ensure development and execution of the clinical integration plan.
  • Supports clinical teams in gathering and reporting various performance metrics for quarterly BU Management Review meetings.
  • Plans, schedules, and conducts vendor audits.
  • Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.
  • Review, revise, update and maintain Clinical AVL and manages updates to the clinical vendor audit database.


What we’re looking for in you:

Required Qualifications:

  • Minimum of a Bachelor’s degree
  • Minimum of 8 years of relevant experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines
  • Minimum of 5 years of clinical QA or compliance experience
  • Minimum of 3 years of direct clinical quality (GCP) auditing experience
  • Travel of approximately 30- 50% can be expected


Preferred Qualifications:

  • Medical device industry experience
  • GCP/auditing certification
  • Experience in hospital setting


Requisition ID: 510842


As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.


So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


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