Quality Analyst I

Additional Locations: Canada-ON-Toronto; Canada-ON-Mississauga

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

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.

Your responsibilities will include:

• 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 and.


• 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.

Required qualifications:

• 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.

Preferred qualifications:

• 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)

Requisition ID: 623040

Minimum Salary: $49700 

Maximum Salary: $98900 

The anticipated compensation and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. 

Compensation for hourly, non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for salaried, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!