Quality and Compliance Specialist - Diagnostic Services

Position Overview

Under the general supervision of the Quality Director Diagnostic Services the incumbent is responsible for:

• General Quality Management System (QMS) oversight of all Shared Health Diagnostic Service (SHDS) areas.
• Ensuring that SHDS areas meet or exceed all regulatory and accreditation requirements necessary to be licensed and/or accredited including Good Manufacturing Practices (GMP).
• Other duties and functions related to this job description not exceeding the stated skills and capabilities.
• Oversight of Pharmacovigilance program(s).

Experience

• Minimum 3 years' experience in a Quality Assurance capacity.
• Previous work experience within a GMP environment.
• Previous experience as a quality auditor/inspector.
• Project management.
• Knowledge of or experience with accreditation, regulations and quality requirements as they pertain to agencies such as, but not limited to:
  • Health Canada
  • Manitoba Quality Assurance Program
  • College of American Pathologists
  • ISO
  • CAR
• Knowledge of or experience with data analysis and basic statistics.

Education (Degree/Diploma/Certificate)

• BSc in chemistry, biological sciences or related field. OR;
• Graduate from an accredited program with a focus on Diagnostic Services within healthcare such as:
  • Medical Laboratory Technology
  • Medical Imaging Technology
  • Cardiology Technology
• Certificate in Quality Management preferred.
• A suitable combination of education and experience may be considered if there is demonstrated experience specific to the responsibilities of the position.

Certification/Licensure/Registration

• Current registration/licensing with applicable professional body.
• May be required to be designated as a Nuclear Energy Worker (NEW) relative to applicable Canadian Nuclear Safety Commission (CNSC) legislation.

Qualifications and Skills

• Adheres to SHDS policy/procedure.
• Adheres to required timelines for conducting tasks related to quality systems requirements and reporting.
• Ability to make risk-based decisions that reflect regulatory requirements and internal policy.
• Effective interpersonal skills and a demonstrated ability to promote teamwork, collaboration and partnership.
• Ability to identify and prioritize options as potential solutions to problems and issues.
• Effective time management skills.
• Ability to work under pressure to meet competing demands and deadlines and deal effectively with difficult and sensitive situations.
• Able to establish and maintain productive working relationships by demonstrating tact, discretion, diplomacy, behavioural flexibility and effective verbal and written communication.
• Ability to work independently and remotely at times.
• Windows computer environment considered an asset.
• Microsoft Office programs considered an asset.
• Workplace Health & Safety Program or training preferred.
• Demonstrated ability to work with and communicate with accrediting bodies and regulators.

Physical Requirements

• Work primarily in an office environment.
• Travel within Manitoba to SHDS sites may be required.
• May be exposed to radiation, not exceeding levels deemed to be safe according to internal policy and CNSC legislation.