Boston Scientific · 4 hours ago
Senior Quality Assurance Engineer
Arden Hills, MN
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $162K/yr
5+ years expBoston Scientific is a leader in medical science committed to solving significant health industry challenges. The Senior Quality Assurance Engineer will prepare complex product performance responses to restore confidence in Boston Scientific products and ensure compliance with regulatory standards.
Health CareMedicalMedical Device
No H1B
Responsibilities
Prepares/drafts timely responses to complaint related product performance requests from global regulators and physician-customers incorporating information from subject matter experts, approved product labeling, and quality records
Develops a comprehensive response strategy and seeks cross-functional subject matter experts to secure required technical and clinical information
Coordinates response reviews/approvals with subject matter experts and management
Delivers final response to government-regulator and physician-customer ensuring accuracy, readability, and consistency
Prepares and presents request metrics to management, seeking opportunities to reduce requests from global regulators by understanding emerging patterns/trends in requests
May review/edit draft communications prepared by others that are intended for external audiences (e.g., field action letters, audit responses, regulatory reports, etc.)
Mentors Complaint Management Center in formulating product performance communication strategies and messages, including the development of template responses
Provides input for process improvements, and initiates/supports continuous improvement projects at a departmental and global post market/quality level
Qualification
Required
Bachelor's degree + 5 years of industry experience [Master's degree + 3 years]
Medical device/regulated industry experience
Strong communication, writing, editing, and presentation skills
Preferred
Bachelor's degree is preferred in a science / health/ engineering
Familiarity with interventional cardiology and peripheral vascular intervention medical devices preferred; knowledge with endoscopy and/or urology medical devices are also an asset
Experience with government-regulators and physician-customers communications
Understanding of medical device reporting regulations and requirements
Complaint handling and Quality System processes experience
Strong analytical and problem-solving skills
PC literacy in word processing, spreadsheets, presentation applications, database management, and dashboards (Microsoft O365)
Project management experience
Experience working with GenAI technology and BOTs
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
2026-01-24
2026-01-23
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