Senior Quality Assurance Engineer

Additional Location(s): US-MA-Marlborough; US-MN-Maple Grove

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.           

About the role: A global position in Post Market Quality Assurance offering exposure to all Boston Scientific products and business units. Opportunity to restore and solidify government-regulator and physician-customer confidence in our products, at a time when a recent adverse event involving Boston Scientific product(s) may have inspired doubt.

 

A Quality Assurance Engineer in Post Market Communications will prepare written product performance responses of high complexity to customers including government regulatory agencies, notified bodies, physicians, patients, sales representatives, and internal employees to promote or restore confidence in the quality and reliability of Boston Scientific products and services.

 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

 

Relocation assistance is not available for this position at this time.

 

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

 

 

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 + 5 years of industry experience [Master’s degree + 3 years].
• Medical device/regulated industry experience.
• Strong communication, writing, editing, and presentation skills. 

 

 

Preferred qualifications:

• 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