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Canada-Quality Assurance Associate Ii (Scientific) #: 23-09980
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Quality Engineer Ii, Design Assurance
Company | Boston Scientific |
Address | Mississauga, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing |
Expires | 2023-08-06 |
Posted at | 10 months ago |
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 II 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.
Your Responsibilities Will Include
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!
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 II 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.
Your Responsibilities Will Include
- Familiarity with requirements of ISO 14971, Manage and update product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs.
- Plans, organizes and prioritizes own daily work routine to meet established schedule.
- Represent Quality by supporting quality disciplines, decisions, and practices.
- Other duties as required.
- 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.
- Identify and drive continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
- 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.
- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
- Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Strong written/verbal communication skills
- Demonstrated interpersonal skills with ability to work within a team environment
- Must be able to work independently under limited supervision
- 3+ years of relevant work experience
- Bachelor’s degree in Biomedical Engineering, Mechanical, Chemical Engineering or related field of study
- Six Sigma problem solving methodologies
- Training experience to FDA regulations or ISO standards
- Experience in the medical device industry
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!
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