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About the Role

As a Quality Analyst II, you will support the quality and compliance of medical devices by managing nonconforming events, corrective and preventive actions, and supplier quality activities within a regulated Quality Management System. You will work closely with cross-functional partners to investigate quality issues, determine root cause, assess risk, and implement effective corrections and corrective actions. You will also support internal audits and external MDSAP audit readiness by maintaining accurate, objective evidence and ensuring quality records meet procedural and regulatory expectations.

Responsibilities

Manage assigned NCEP records, including investigation support, containment, risk assessment, disposition activities, escalation assessment, and timely closure in accordance with applicable procedures.
Support CAPA activities by defining the problem statement, facilitating root cause analysis, documenting investigation outcomes, supporting solution planning, and verifying the effectiveness of implemented actions.
Coordinate supplier quality activities, including supplier-related nonconformances, supplier communication, SCAR or escalation support, and follow-up to ensure appropriate corrective actions are completed.
Collaborate with cross-functional teams such as Operations, Regulatory Affairs, Customer Care, Supply Chain, Field Service, and other business partners to investigate quality issues and implement practical, compliant solutions.
Review quality data, trends, and objective evidence to identify potential quality signals, support risk-based decision making, and recommend process improvements.
Maintain accurate, complete, and audit-ready quality records, ensuring rationale, approvals, attachments, and objective evidence are clearly documented.
Perform or support internal Quality Management System audits, including audit planning, evidence review, documentation of findings, and follow-up on corrective actions.
Support external MDSAP and other regulatory or notified body audits by preparing records, responding to document requests, and coordinating timely responses with process owners.
Partner with stakeholders to drive continuous improvement and ensure compliance with applicable quality system standards, procedures, and regulatory requirements.

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, Co-pilot etc.
Minimum 3 year working experience in a regulated environment
Knowledge of statistical analysis and quality improvement methodologies.
Working experience with SAP S4/HANA
Good listening, and verbal/written communication skills with demonstrated ability to follow instructions and processes
Strong problem-solving, time-management and organizational skills
Ability to work independently and as part of a team in a fast-paced environment

Skills

Microsoft Office suite
Statistical analysis
Quality improvement methodologies
SAP S4/HANA
Problem-solving
Time-management
Organizational skills
Communication skills

Location

Canada-ON-Toronto
Canada-ON-Mississauga
Brampton

Work Type

Hybrid

Experience Level

Minimum 3 years working experience in a regulated environment

Education Level

Bachelor's degree in Engineering, Life Sciences, or a related technical field.

Salary/Compensations

$59,900
$108,900

Benefits

Core and optional employee benefits offered by Boston Scientific (BSC)

About the Company

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.

Equal Opportunity

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