Quality Analyst

Smith+Nephew•Mississauga, ON

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. As a Quality Analyst, you will play a key role in ensuring our Quality Management System supports safe, compliant and high quality products for patients across Canada. Working closely with cross functional teams and subject matter experts, this role offers the opportunity to make a meaningful impact while developing your expertise within a global medical technology organization.

Requirements

Bachelor’s degree in science, business or a related discipline
Quality Management System (QMS) certification with no prior experience, or 2–4 years of experience in quality, regulatory, or other regulated environments in lieu of certification.
Knowledge of Quality Management Systems and an understanding of GMP principles
Familiarity with Canadian regulatory requirements is preferred
Strong communication, organizational and problem solving skills
Ability to work independently while collaborating effectively across teams
Proficiency in Microsoft Office and comfort working with electronic quality systems
Fluency in written and spoken English, with French considered an asset

Responsibilities

Supporting the establishment, maintenance and continuous improvement of the Canada Quality Management System to ensure regulatory compliance
Executing and monitoring core QMS processes including CAPAs, complaints, adverse events, audits, document control, training and management review activities
Managing product complaints and adverse event reporting, including preparation and submission of reports to Health Canada within required timelines
Coordinating recall related activities and quality notifications to ensure appropriate actions are taken
Partnering with Operations and other internal teams to resolve quality issues and support day to day quality assurance activities
Maintaining quality records, metrics and reports and identifying trends to drive process improvements
Providing quality guidance and support to internal teams and responding to customer quality related inquiries