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Quality Assurance Engineer

2 months ago

Mississauga, Ontario, Canada Boston Scientific Full time

About the Role

We are seeking a dedicated Quality Assurance Engineer to contribute to our growing team. This role will focus on ensuring that new products meet internal and external requirements through robust risk management, design controls, production processes, and continuous quality improvement initiatives.

Your Responsibilities:

  • Collaborate with New Product Development teams to implement effective controls throughout the product lifecycle, ensuring compliance with industry standards and regulations.
  • Develop a comprehensive understanding of Design Controls, Risk Management methodologies, and Usability Engineering principles specific to medical devices.
  • Apply structured problem-solving techniques to identify and resolve quality issues effectively.
  • Stay informed about current best practices and industry standards within the medical device sector.
  • Contribute to departmental goals by supporting design quality assurance initiatives and compliance improvement projects.
  • Maintain a strong commitment to quality by adhering to all relevant quality requirements in every aspect of your work.

Required Qualifications:

  • Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
  • Minimum 1 year of experience working within the Medical Device Industry.
  • Demonstrated ability to work effectively as part of a team and foster collaborative relationships.
  • Excellent written and verbal communication skills.
  • Willingness to travel occasionally (less than 25%).

Preferred Qualifications:

  • Experience with Six Sigma problem-solving methodologies.
  • Knowledge of ISO 13485, ISO 14971, and IEC 60601 standards.
  • Background in medical imaging technologies.