Quality Assurance Leader in Medical Devices

Join Arbutus Medical as a Quality Assurance Leader, managing quality systems critical to our operation in Burnaby. Focus on ISO compliance and operational excellence during facility changes.

As the first dedicated Quality Assurance professional, you will spearhead our Quality Management System (QMS) while ensuring we meet regulatory standards throughout our facility relocation. This role is designed for candidates with significant experience in the medical device field and a capacity to execute quality strategies that drive operational efficiency.

Key Responsibilities:

• Lead the development of an ISO 13485-compliant QMS

• Ensure thorough audit and compliance readiness

• Manage quality documentation and process controls

• Facilitate the ISO 13485 surveillance audit preparation

• Oversee CAPA processes and reporting

Requirements:

• 5-10+ years in Quality Assurance within medical device environments

• In-depth knowledge of ISO 13485 and FDA regulations

• Experience with internal and external auditing

• Technical background in a related field is beneficial

• Exceptional communication for engaging with stakeholders

Shape the future of quality assurance at Arbutus Medical as we grow in Burnaby.
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