Alimentiv is hiring a
Sr. Quality Assurance Specialist, Remote - Canada

Summary

The Senior Quality Assurance Specialist - Medical Device is a senior technical expert responsible for planning and executing Quality Assurance deliverables in the medical device field. The role requires advanced knowledge of regulations and standards governing medical imaging, AI/machine learning, and software as a medical device (SaMD).

Requirements

• Minimum of a bachelor's degree with 7-9 years of related experience and on-the-go training
• Fluent in the reading, writing, and speaking of English (other language skills preferred)

Responsibilities

• Plan and execute Quality Assurance deliverables
• Oversee and evaluate the technical aspects of the work performed by the department
• Provide technical mentoring to the Quality Assurance staff
• Develop, implement, and track compliance of QA plans (study, internal process and annual)
• Project manage department projects and deliverables to ensure work is of high quality
• Monitor, evaluate quality indicators, QA reports and audit responses
• Support study operational teams with resolution of escalated issues
• Identify quality risks and work with leaders to design mitigation strategies
• Lead investigations, audits or QA related corporate initiatives and mentor other QA staff in the performance of these activities

Preferred Qualifications

• Certification in GCP, ISO 13485, or MDSAP, auditing
• Knowledge of regulations and standards governing medical imaging, AI/machine learning and software as a medical device (SaMD)

Benefits

• Home-based (with accommodations for job applicants with disabilities)
• $86,500 - $144,000 a year