Boston Scientific Senior Quality Assurance Engineer 

United States, Minnesota 

572091889

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.
• 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.

Required qualifications:

• Bachelor’s degree and a minimum of 5 years of industry experience OR a Master’s degree and a minimum of 3 years of experience.
• Medical device/regulated industry experience.
• Strong communication, writing, editing, and presentation skills.

Preferred qualifications:

• Bachelor’s degree is preferred in a science / health.
• Familiarity with cardiac rhythm management and/or neuromodulation medical devices.
• Experience with government-regulators and physician-customers communications.
• Complaint handling and Quality System processes experience.
• Strong analytical and problem-solving skills
• Project management experience.
• PC literacy in word processing, spreadsheets, presentation applications, and database management
• Artificial intelligence/automation technologies experience

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.