Boston Scientific · 15 hours ago
ClinicalQA - P5
Maple Grove, MN
Full-time
Hybrid
Senior Level, Lead/Staff
$107K/yr - $203K/yr
8+ years expBoston Scientific is a leader in medical science committed to solving health industry challenges. The Principal Quality Engineer will oversee the quality framework for Health Care Professional training and provide Clinical Quality Assurance leadership, ensuring compliance with medical device standards and regulations.
Health CareMedicalMedical Device
No H1B
Responsibilities
Serve as the quality expert for CQA and HCP training, leading teams through BSC’s Quality System and acting as the SME for interpreting regulations and translating them into practical, compliant processes
Represents ICTx and WM HCP Training interests in the Global HCP Training CoP. Proactively addressing relevant topics with a keen focus on enhancing compliance, effectiveness, and efficiency of HCP training processes
Own and develop the HCP QA Assessment Schedule; oversee execution by HCP QA staff and provide strategic, tactical, and technical guidance during assessments and follow-up
Leads quality escalations discussions with global, cross-functional partners; drives and oversees NCEPs, CAPAs, and SCARs; owns corrective and preventive actions as needed
Design, implement, and sustain global quality systems; lead cross-product, cross-division best-practice sharing to boost compliance, effectiveness, and efficiency of HCP training in both commercial and clinical settings
Prepare, coordinate, and support regulatory inspections at BSC offices and clinical sites; partner with clinical leadership and CQA peers to maintain an audit-ready state for all WM and ICTx studies
Champion proactive, data-driven compliance—using metrics to identify risks, drive process improvements, and strengthen a culture of quality
Demonstrate an unwavering commitment to patient safety and product quality by adhering to the Quality Policy and all documented processes and procedures
Ensure the right resources (people, tools, and systems) are available to sustain Quality System compliance and adherence to the BSC Quality Policy
Foster a work environment that models and reinforces the Quality Policy and Quality System
Qualification
Required
Bachelor's degree in Science, Health, Engineering, or a related field
8 plus years of experience in medical device, pharma, or a similarly regulated industry
Exceptional organization and the ability to influence without authority at all levels
Strong presentation and communication skills
Proven collaboration and critical-thinking skills
Preferred
Working knowledge of U.S. and international regulations and standards applicable to BSC
Direct experience developing and implementing a Learning Management System for Physician Training Records globally
Direct experience owning and driving quality assurance activities in support of NCEPs and CAPAs
Experience in Medical Education and/or Clinical Quality Assurance
Familiarity with BSC IT systems (e.g., eCAPA, Windchill, APPROVE)
Experience partnering with cross-functional teams such as Regulatory, R&D, Clinical, Medical, Sales Training, and Quality
10 plus years of experience in medical device, pharma, or a similarly regulated industry
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
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
BioWorld Financial Watch
2026-01-16
2026-01-16
2026-01-16
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