Technical Quality Specialist - Regulatory Compliance

Reports to: Manager, Regulatory Compliance   Purpose of the Role   Provide medical laboratory leadership, discipline-specific technical expertise and quality management consultation to Operations. Ensure processes and procedures remain current and compliant with scientific advancements, technical developments and regulatory requirements of their discipline-specific field of Medical Laboratory Science.   Your responsibilities will include: Provide troubleshooting, technical and quality assurance/quality systems support for methodologies, equipment and supplies currently in use. Ensure department policies, processes, procedures and forms remain current with applicable regulations, legislation, and best practice. Lead in-function projects and act as subject-matter experts for cross-function projects, as appropriate. Support the internal/external assessment process and collaborate with stakeholders to develop and implement corrective actions Liaise with external stakeholders including the Diagnostic Accreditation Program (DAP) and Accreditation Canada Diagnostics (ACD) Provides support to Medical/Scientific, Supply Chain Management, Business Development, IT and other support departments as required.   What you bring to the role: College Diploma in Medical Laboratory Technology or equivalent education and experience. In Ontario, current registration with College of Medical Laboratory Technologists of Ontario (CMLTO). In British Columbia, current registration with Canadian Society for Medical Laboratory Science (CSMLS). Minimum of 3 years previous discipline-specific laboratory experience Strong technical and quality systems knowledge and understanding to provide discipline specific, expert technical and scientific support to all customers, internal and external. Proven ability to facilitate compliance with the Quality Management System within a regulated environment A clear understanding of regulatory compliance processes and the business impact of failing to meet external regulatory requirements. Facilitation skills necessary to lead discipline specific teams, and the confidence to conduct audits, issue non-conformance reports requiring correction actions, and follow-up on continues non-compliance. The ability to use sound risk management analysis to assess the regulatory and business impact of prioritizing goals. Excellent verbal communication skills to effectively communicate decisions and seek input. Excellent technical writing skills to support the creation, review, and maintenance of documentation. Strong organization, change and project management skills to ensure that deliverables are achieved on schedule and in a controlled manner. Occasional travel required This is an in-person role.