Quality Analyst I

Role overview

Boston Scientific is seeking an entry-level Quality Analyst I to support the quality and compliance of medical devices across the post-market phase. The role focuses on complaint processing, accurate documentation, and assistance with recall and advisory notice work. You will collaborate with multiple teams to keep quality processes timely, compliant, and aligned with global regulatory expectations while supporting patient safety.

Work locations

This position is based in Toronto, Ontario, Canada, with additional locations listed in Canada-ON-Toronto and Canada-ON-Mississauga.

What you will do

• Handle incoming product complaints in line with quality standards and regulatory obligations, ensuring the process is efficient and controlled.
• Support product recall and advisory notice activities, including accurate and timely communication with customers and sales teams across business groups.
• Manage workflow to help achieve core operational performance targets.
• Prepare, update, and archive controlled documents while following company policies and regulatory requirements.
• Keep records complete, well-organized, and accurate for controlled documents and related activities.
• Work with teams such as Regulatory, Customer Care, Sales, and Marketing to promote understanding of quality expectations.
• Spot quality problems, help address non-conformance issues, and support corrective actions.
• Suggest and implement process enhancements where appropriate.
• Take part in internal and external audits related to ISO 13485 and Health Canada compliance.
• Carry out additional duties as needed.

Required background

• A bachelor’s degree in Engineering, Life Sciences, or another relevant technical discipline.
• Working knowledge of ISO 13485, quality system requirements, and CMDR SOR/98-282.
• Comfort using Microsoft Office tools, including Word, Excel, Outlook, PowerPoint, and Teams.
• Strong focus on detail and the ability to maintain orderly, compliant records.
• Good communication skills and the ability to work effectively with cross-functional partners.
• Ability to learn and follow established procedures in a regulated environment.

Preferred experience

• About 1 year of experience in a regulated environment.
• Post-secondary training in regulatory affairs or quality management.
• Familiarity with statistical analysis and quality improvement methods.
• Exposure to complaint handling systems, CAPA workflows, or field action/recall processes.
• Experience using quality documentation and record-management tools such as an electronic QMS or ERP system.

Compensation and benefits

The role carries an annual base salary range of CAD 49,700 to CAD 98,900. Total compensation and benefits may vary based on location, experience, education, licensure, certifications, and business needs. For salaried non-sales positions, compensation may also include annual bonus opportunities and long-term incentives, subject to plan eligibility and other requirements. For hourly non-sales positions, variable pay such as overtime or shift differentials may apply, along with an annual bonus target where eligible.

About the company

Boston Scientific is a global medical technology company that has spent more than 45 years developing innovative solutions that improve patient outcomes and help lower healthcare costs. Its portfolio supports physicians in diagnosing and treating complex cardiovascular, respiratory, digestive, oncological, neurological, and urological conditions.

Additional information

The organization emphasizes diversity, innovation, caring, global collaboration, a winning spirit, and high performance. Employees are supported with tools, information, and training to grow their skills and careers. Requisition ID: 630857.