NDI Senior Engineer Quality Assurance Medical Devices

Location: Southwestern Ontario

Make a difference in healthcare technology as a Senior Quality Engineering Specialist at NDI, located in Waterloo, Ontario. This role focuses on ensuring that medical devices meet the highest standards of safety and regulatory compliance.

Reporting to the Senior Manager, you will be integral in managing quality throughout the product lifecycle, from initial design through commercialization and beyond. You will engage with R&D and manufacturing teams, leveraging your skills to lead risk management activities and support quality documentation, aligning NDI's innovations with global standards.

Key Responsibilities:

• Direct quality engineering from design to post-market phases

• Ensure compliance with ISO 13485 and FDA essentials

• Lead design controls, validation, and change processes

• Conduct investigations and address regulatory findings

• Collaborate with teams for quality in production

Requirements:

• Bachelor's in Engineering or a related discipline

• 9+ years in quality engineering, primarily in medical fields

• Certification as a Quality Engineer is advantageous

• Knowledge of risk management ISO standards

• Strong communication and detail-oriented approach

Leverage your expertise in quality engineering to shape the future of medical devices at NDI.
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