Senior Quality Engineer

Additional Locations: Canada-ON-Mississauga

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

This role offers an individual the opportunity to be part of the Access Solutions Complaint Investigation Site within the Post Market Quality Assurance team at Boston Scientific. The primary activity for this role is to complete product analysis for investigations of field complaint allegations against Boston Scientific products. This position is a vital part of improving patient care by ensuring Boston Scientific device allegations are investigated efficiently and effectively.

 
Your responsibilities will include:

• Completing investigations and reviewing/approving returned product analysis results to ensure field allegations are adequately addressed.
• Identifying and resolving processing/system issues using engineering essentials and other related problem-solving tools and techniques, while meeting organizational and regulatory requirements.
• Partnering with team members (and cross-functional teams) to ensure the development and execution of streamlined robust solutions to post-market quality processes are effectively implemented.
• Focusing on continuous improvement by championing and fostering the execution of projects within the Post Market Quality department.
• Fostering a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Serve as a support role for other activities within in the Complaint Investigation Site as needed (such as: responding to Technical Service Requests, communicating product quality issues to Sr. management, etc.)
• Will participate and lead project work for the Access Solutions Product Performance Team and Post Market Quality Assurance Global Team.
• Adhere to all requirements of the Quality Management System. 
• Demonstrate company values, work with integrity, and be a supportive team member. 
• Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.  
• Other duties as required. 

 
Required qualifications: 

• Bachelor's Degree in Engineering or related Science
• 5+ years of relevant work experience
• Demonstrated problem-solving capabilities
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
• Ability to collaborate and influence across multiple, cross-functional teams

Preferred qualifications: 

• Understanding and working knowledge of Medical Device Quality Systems and Regulatory Requirements
• Clinical knowledge of cardiology procedures
• Experience in the medical device industry
• Continuous improvement and Six Sigma experience

Learn more about our Transseptal Access Devices

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Requisition ID: 592812

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!