Senior Quality Assurance Engineer

Boston Scientific • Arden Hills, MN

2d

About The Position

Your responsibilities will include: 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. Provides input for process improvements, and initiates/supports continuous improvement projects at a departmental and global post market/quality level.

Requirements

• 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.
• Bachelor's degree is preferred in a science / health/ engineering.
• 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.

Nice To Haves

• Familiarity with interventional cardiology and peripheral vascular intervention medical devices preferred; knowledge with endoscopy and/or urology medical devices are also an asset.

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.
• Provides input for process improvements, and initiates/supports continuous improvement projects at a departmental and global post market/quality level.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level