Quality Assurance Associate

Bayshore•Markham, ON

7h•Onsite

About The Position

The Quality Assurance (QA) Associate, under the direction of the Manager, Quality will support the implementation and maintenance of the Quality Management System (QMS), Document Management System (DMS) and Learning Management System (LMS), participate in quality improvement initiatives, and the development of policies, procedures, and education materials to support the business. The incumbent will support the assigned business lines with Quality Events, Risk Management, Privacy Management as well as Internal and External Audit Program. Occasionally this position may provide support to other business lines as deemed appropriate by the Quality Management team.

Requirements

Bachelor’s degree preferably in a health-related field.
At least 3 years of experience in quality assurance, preferably in healthcare or life sciences industry.
At least 2-3 years of DEL and MDEL related experience is preferred.
Experience in the development of policies, SOPs and WIs.
Experience in managing deviations, RCA, and CAPA plan.
Experienced in using quality systems like QMS, DMS, LMS, as well as ERP & CRM applications.
Demonstrated ability and competency in Windows software.

Nice To Haves

ASQ Quality Certification, ISO Auditor Certification, or equivalent quality certification will be considered an asset.
Completion of Quality Management, Risk Management, or related courses is preferable.
Understanding QMS Validation is an asset.
Previous experience working with Health Canada on the medical device establishments would be preferred.

Responsibilities

Participates in the development, implementation and maintenance of Quality Management System and Document Management System.
Ensure processes meet established quality standards and follow all applicable regulatory and legislative requirements and are version controlled via the document change control process.
Conducts Policy, SOP and WI reviews and revisions, participates in the development of new policies, procedures, and SOPs, and performs their efficacy analysis.
Helps ensure appropriate training assignment on approved procedural documents including appropriate communication to all employees.
Maintains regular on-site presence to address any quality-related issues by partnering with relevant stakeholders (including supply chain, logistics and warehouse staff).
Provide on-the-floor support for audit readiness and quality-related queries.
Perform on-floor quality checks and line clearance activities as needed to ensure compliance with internal policies, procedures, and operational standards.
Assist with on-site quality activities by performing basic compliance checks and promptly reporting any issues to the quality team.
Support on-the-floor quality training initiatives as and when needed.
Supports management of quality events (deviations). Conducts root cause analysis, investigations and ensures CAPA plan is effective and closes on time. Support implementation of corrective and preventive actions by working closely with on-site stakeholders. This will require education / onsite coaching, coordination, and collaboration across the team with all internal stakeholders. Assists with quality event trends analysis and resulting improvement initiatives.
Supports internal audit program and spot audits on-site as required to ensure compliance and assist in retrieving documents during onsite External Audits.
Identifies training needs, participates in the development of training materials, and leads training to meet quality management standards and contractual requirements.
Educates internal stakeholders on key quality deliverables and identifies process improvements to increase efficiency, effectiveness, and quality.
Assist in coordinating with quality team members and other departments to support ongoing initiatives and share process improvements.
Perform other duties as assigned.