Principal Clinical Quality Assurance Specialist

Additional Locations: Belgium-Diegem

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.

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Our Rhythm Management Clinical Quality Assurance team rigorously pursues adherence to good clinical practice within some of the most challenging clinical device trials conducted in pursuit of transforming lives with groundbreaking technologies that address irregular heart rhythms, heart failure and sudden cardiac arrest.

We are seeking an engaging and qualified Principal Clinical Quality Assurance Specialist who is aligned with our core values that define Boston Scientific culture and empower our employees:
Caring - Meaningful innovation - High performance - Global collaboration - Diversity - Winning spirit. Because a career with Boston Scientific is more than just a job. It’s personal. We’re committed to solving some of healthcare’s toughest problems – united by a deep caring for human life. If you’re a natural problem‑solver with the imagination, courage, and spirit to make a meaningful difference in clinical quality, there’s no better place to build your career.

This is a high visibility hybrid position supporting a global Clinical team conducting investigational electrophysiology and cardiac rhythm management/diagnostic medical device studies at global sites. Qualified OUS candidates are encouraged to apply.

• 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 provide 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…