Additional Locations: Canada-ON-Toronto; Canada-ON-Mississauga
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. In this role, 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.
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local Brampton office at least three days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.
Your responsibilities will include: - 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.
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, Co-pilot etc.
Preferred qualifications: - 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
Requisition ID: 632177
Minimum Salary: $59,900
Maximum Salary: $108,900
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).
