Quality Engineer Iii, Design Assurance

Additional Locations: Canada-ON-Mississauga; 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
Our team is growing, and we are currently looking for a Quality Engineer III to join our Design Assurance Quality team. This position works closely with new product introduction teams to ensure adequate design controls are met and subsequent production and process controls for the project are adequate. This is an intermediate-level Engineering position.
Your Responsibilities Will Include

• Plans, organizes and prioritizes own daily work routine to meet established schedule.
• Identify and drive continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
• Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• Represent Quality by supporting quality disciplines, decisions, and practices.
• Understanding of Design Assurance requirements to support product design & development & design changes through cross-functional team collaboration, to ensure activities comply to all internal and regulatory requirements.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Other duties as required.
• Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Familiarity with requirements of ISO 14971, Manage and update product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs.

Required Qualifications

• Demonstrated interpersonal skills with ability to work within a team environment
• 3+ years of relevant work experience
• Strong written/verbal communication skills
• Bachelor’s degree in Biomedical Engineering, Mechanical, Chemical Engineering or related field of study
• Must be able to work independently under limited supervision

Preferred Qualifications

• Experience in the medical device industry
• Six Sigma problem solving methodologies
• Training experience to FDA regulations or ISO standards

Requisition ID: 569638
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!