Senior Clinical Quality Assurance Specialist

Senior Clinical Quality Assurance Specialist

Onsite Location(s):
Arden Hills, MN, US, 55112

Additional Location(s): US-MN-Maple Grove; US-CA-Valencia; US-MA-Marlborough

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.

* Please note this position can be based out of any US Based Office Location

We are seeking an engaging and qualified Senior Clinical Quality Assurance Specialist who is aligned with Boston Scientific’s core values: caring, meaningful innovation, high performance, global collaboration, diversity, and winning spirit. A career with Boston Scientific is more than just a job — it’s personal. We are committed to solving some of health care’s toughest problems, united by a deep caring for human life.

This hybrid role supports a global Clinical organization conducting investigational device trials at sites worldwide. If you are a natural problem solver with the imagination, courage, and drive to make a meaningful impact in clinical quality, this is an opportunity to build your career while advancing patient care. Qualified U.S.

-based candidates are encouraged to apply.

Work model, sponsorship, relocation: 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. Relocation assistance is not available for this position at this time.

• Clinical compliance: Serve as the clinical quality representative on clinical trial project teams, bringing the voice of clinical quality and fostering a continuous state of inspection readiness.
• Provide clinical quality consultation and respond to compliance and regulatory questions, including quality review of clinical study documents and related functional study plans.
• Support the Inspection Readiness Program, including inspection readiness training and coordination and participation in mock BIMO inspections and external inspections.
• Communicate with global clinical teams and Strategic Clinical Sourcing regarding clinical vendors, including new vendor requests, current needs, and future requirements.
• Create risk-based study audit plans and plan, schedule, and conduct investigator site audits; support internal clinical process audits and clinical vendor audits as needed to ensure compliance with regulatory requirements, quality standards, GCP, and Boston Scientific policies and procedures.
• Document and communicate audit observations, evaluate impact, and make recommendations for corrections and corrective actions.
• Evaluate responses to audit findings and ensure appropriate corrections and corrective actions are initiated and completed in a timely manner.
• Stay current on worldwide regulatory requirements and advise stakeholders on potential impacts of regulatory changes.

• Support divisional and global Clinical and Quality System teams during external regulatory and notified body audits.
• Support the CAPA program by providing quality input for assessing internal noncompliance and recommending initiation of corrections and CAPAs, partnering closely with Clinical CAPA teams and owners through successful closure.
• Participate in clinical and clinical quality continuous improvement initiatives and project teams.
• Review and provide input on relevant Boston Scientific procedure revisions.
• Support departmental, divisional, and corporate quality goals and priorities.

• Represent Clinical Quality on acquisition and integration teams, supporting the identification, assessment, and mitigation of risks associated with the review and/or transfer of sponsorship of…