Quality Analyst I

Boston Scientific•Toronto, ON

6d•CA$49,700 - CA$98,900•Hybrid

About The Position

In this entry-level position, you will support the quality and compliance of medical devices throughout their post‑market lifecycle. You will be responsible for complaint intake, documentation accuracy, and supporting recall and advisory notice activities. Working closely with cross‑functional teams, you will help ensure timely, compliant processes that safeguard patient safety and meet global regulatory standards.

Requirements

Bachelor's degree in Engineering, Life Sciences, or a related technical field.
Knowledge of ISO13485, Quality System standards, and CMDR SOR/98-282
Proficient with Microsoft Office suite – Word, Excel, Outlook, PowerPoint, Teams, etc.
Strong attention to detail and the ability to maintain organized, compliant documentation.
Solid communication skills and comfort working cross‑functionally.
Ability to learn and follow established procedures in a regulated environment.

Nice To Haves

1 year working experience in a regulated environment
Post-secondary education in regulatory and quality management
Knowledge of statistical analysis and quality improvement methodologies.
Exposure to complaint handling systems, CAPA processes, or field action/recall activities.
Proficiency in tools used for quality documentation and record management (e.g., electronic QMS, ERP systems)

Responsibilities

Responsible for complaint intake process and ensure efficiency and adherence to quality standards and regulatory requirements
Assist with product recalls and advisory notice activities to ensure compliance with procedures and regulatory policies timely and accurate communication with customers and sales teams across all divisions, manage workflow to meet core operational performance metrics
Oversee the creation, revision, and archiving of controlled documents, ensuring compliance with regulatory requirements and company policies.
Maintain accurate and organized records of all controlled documents and related activities.
Collaborating with cross-functional teams including Regulatory, Customer Care, Sales, and Marketing to ensure understanding of quality requirements
Identify and resolve quality issues and manages addressing non-conformance matters.
Recommend and implement process improvements.
Participate in internal and external audits to ensure compliance with ISO 13485 and Health Canada regulations
Other duties as required.