Sr. Quality Engineer

Additional Locations: Canada-ON-Toronto

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 Product Performance team within the Post Market Quality Assurance team at Boston Scientific. The primary activity for this role is to lead and support post market quality assurance activities related to Boston Scientific products. This position is a vital part of improving patient care by monitoring Boston Scientific devices to ensure they are performing safely and effectively. 
 

Your responsibilities will include:

• Provide Quality Engineering support for the Post Market Design Assurance team. 
• Navigate government regulations and standards, including Regulation (EU) 2017/745, 21 CFR 820, ISO 13485 and ISO 14971. 
• Collaborate with engineering, clinical and other functions to ensure quality requirements are met.
• Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk. 
• 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.
• Attend communities of practice for Post Market Surveillance and provide training to affected members of the organization when new or updated quality system requirements are released.
• Draft and review post market surveillance and post market clinical follow-up reports.
• Prepare and present post market data and recommendations to cross-functional groups.
• Support internal and external audits as required. 
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• 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 required. 
• 4-5 years of medical device experience, or advanced degree with a minimum of 3 years medical device experience. 
• A strong understanding of post market surveillance activities including post market clinical follow-up. 
• Must be a critical thinker and active listener with good time management skills. 
• Self-starter with the ability to quickly learn about new processes. 
• Excellent analytical and communication skills (written and oral). 
• Ability to work effectively within a team and across functions. 

Preferred qualifications:

• Experience working in a quality role at a medical device company.
• Experience with post-market surveillance, including cybersecurity.
• Experience with post market clinical follow-up and other clinical risk activities.
• Experience working with PLM (Windchill) and ERP (MES and/or SAP) software.
• Experience with quality system integration. 
• Experience with risk remediation projects.

Requisition ID: 580419

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!