Senior Quality Engineer - Electrophysiology

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

Our team is growing, and we are currently looking for a Senior Quality Engineer to join our team. This position requires leadership skills that would enable the Senior Quality Engineer to drive major Quality improvement projects across functions.

Your responsibilities will include :

• Provide Quality Engineering support for the Design Assurance team.
• Navigate government regulations and standards, including 21 CFR 820, ISO 13485 and ISO 14971.
• Develop, modify, and maintain quality system (QMS) requirements.
• Collaborate with engineering and other functions to ensure quality requirements are met.
• Collaborate with Research & Development (R&D) Engineers to update Design History Files (DHFs) and meet new requirements.
• Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk.
• Provide training to affected members of the organization when new or updated quality system requirements are released.
• Provide guidance to other team members on common projects.
• Support internal and external audits 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 medical device design controls.
• 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 working with PLM (Windchill) and ERP (MES and / or SAP) software
• Experience with quality system integration.
• Experience with DHF remediation projects.

Requisition ID : 574729

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!