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Quality Assurance Engineer III

2 weeks ago

Mississauga, Ontario, Canada Boston Scientific Gruppe Full time

About the Role

We are currently looking for a Quality Assurance Engineer III to join our Design Assurance team. As a quality representative on a high-performing cross-functional team, this engineer will work closely with the team to ensure risk management is applied and adequate design controls are met.

Responsibilities:

  • Actively promote and participate in a cross-functional teamwork environment.
  • Manage and update product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs.
  • Collaborate within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
  • Use clinical knowledge/data to influence how devices you are working on are tested and designed.
  • Apply judgement to solve problems and determine appropriate action by analyzing possible solutions and their impact on the business.
  • Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Identify and drive continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
  • Bond quality into all aspects of work by maintaining compliance to all quality requirements.
  • Plan, organize and prioritize own daily work routine to meet established schedule.
  • Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
  • 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.