Alimentiv is hiring a
Sr. Quality Assurance Specialist, Remote - Canada
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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
This job is filled or no longer available