Quality Analyst II

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

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:

Develops, establishes and maintains quality data systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality data support for CAPA and Nonconformance management processes.

Your responsibilities will include:

• Design, develop, and maintain Excel sheets and Power BI dashboards to monitor and report on key Quality metrics.
• Analyze data from multiple quality systems to identify trends, risks, and opportunities for continuous improvement.
• Collaborate with cross-functional teams (QA, RA, Operations, Manufacturing, etc.) to define and refine data requirements for effective decision-making.
• Track quality system tasks such as CAPAs, NCRs, Product Inquiry Reports (PIRs), internal/external audits, and change controls.
• Ensure data integrity and accuracy by performing regular data validation and quality checks.
• Generate periodic reports for internal stakeholders and regulatory audits.
• Support root cause analysis and investigations by providing relevant data insights.
• Drive automation and efficiency in data collection and reporting processes.

Required qualifications:

• Bachelor’s degree in Engineering, Computer Science, Statistics, or related field.
• 2+ years of experience in data analytics or business intelligence, preferably in the medical device, pharmaceutical, food manufacturing or healthcare industry.
• Proficiency in Microsoft Power BI (DAX, Power Query, data modeling).
• High level of proficiency in the use of Excel for Data Analysis
• Solid understanding of quality systems and processes (e.g., CAPA, NCR, audits, complaints).
• Strong analytical and problem-solving skills, with the ability to interpret complex datasets.
• Excellent communication skills with the ability to present data-driven insights to both technical and non-technical stakeholders.

Preferred qualifications:

• Experience working in a regulated industry (FDA, ISO 13485, etc.)
• Knowledge of SQL or other database querying languages
• Experience with statistical analysis tools (ie: Minitab, R, Python)
• Understanding of data privacy and compliance requirements
• Lean Six Sigma or quality/process improvement certification

Learn more about our Transseptal Access Devices

Click this link to explore the groundbreaking technology behind our transseptal access devices at Boston Scientific: Transseptal access devices

Requisition ID: 612939

Minimum Salary: $57200 

Maximum Salary: $113700 

The anticipated compensation listed above 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. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

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!