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Quality Assurance Specialist

2 months ago

Calgary, Alberta, Canada Fluid Biomed Inc. Full time
Quality Assurance & Systems Specialist

Fluid Biomed Inc. is seeking a highly motivated and detail-oriented Quality Assurance & Systems Specialist to join our team in Calgary, AB. As a key member of our Quality Department, you will play a critical role in ensuring the development and implementation of our Quality Management System (QMS) in accordance with ISO 13485 standards.

Key Responsibilities:
  • Develop and maintain effective QMS processes and procedures to ensure compliance with regulatory requirements.
  • Lead internal audits to assess QMS effectiveness and identify areas for improvement.
  • Conduct mock audits to prepare the team for external audits and certification.
  • Investigate and resolve nonconformance reports (NCRs) and implement corrective and preventive actions (CAPAs).
  • Manage document control activities, including revision controls, SOP/document review and approval, and document retention and archiving.
  • Develop and maintain an ISO/ASTM/ANSI standards database and conduct gap assessments on newer versions.
  • Manage change control activities, including change requests review and approval, impact and risk assessment, and implementation of approved documents.
  • Review and approve technical and nontechnical documents in compliance with QMS requirements.
  • Prepare and lead QMS Management Review meetings and present to the team and executives.
  • Establish and maintain key performance indicators (KPIs) to monitor QMS effectiveness.
  • Manage overall training program and maintain training KPI reports, matrix, files, and records for all staff.
  • Provide training and education to staff on quality processes, SOPs, and regulations as required.
  • Lead and support quality systems improvement project activities across the organization.
  • Assist in product quality assurance activities, including quality inspection, as required.
Requirements:
  • Bachelor's degree and minimum 2 years' of Quality Assurance and/or Systems experience in an ISO 9001/13485 industry required.
  • Understanding or knowledge of the ISO 13485 requirements required.
  • Demonstrated experience with Quality Management System, and internal/external ISO audit activities required.
  • Experience or knowledge with root cause analysis techniques required.
  • Experience or knowledge with change management process, including impact and risk assessment, required.
  • General understanding of the training process required.
Additional Skills:
  • Certification as Internal Auditor preferred.
  • Excellent documentation, attention to detail, communication (written & oral), and interpersonal relationship skills.
  • Strong problemsolving, organizational, analytical, and critical thinking skills.
  • Ability to navigate uncertainty/fluidity in role scope, priorities, and timelines.
  • Ability to manage competing priorities in a fastpaced and dynamic environment.
  • Proven expertise in usage of MS Office Suite