Quality Analyst Ii jobs at Boston Scientific in Canada, Mississauga

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

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

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

About the role:

Develops, establishes and maintains quality system methodologies, processes, and practices relating to Measurement, Analysis and Improvement, which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on CAPA and Nonconformances to support departmental, functional, site, divisional and corporate quality goals and priorities. Leads a team responsible for maintaining CAPA processes, supporting site CAPA, and providing site expertise on the CAPA system.

Your responsibilities will include:

• Lead and direct a quality systems team on executing processes and quality deliverables associated with NCEPs, CAPAs and quality systems
• Own and assist with administration and management of the NCEP and CAPA process
• Mentor NCEP and CAPAs owners on using systematic problem-solving methodologies for identifying, prioritizing, communicating, and resolving quality issues
• Coach NCEP and CAPA owners on how to investigate, identify, and implement best-in-class and sustainable quality practices
• Communicate effectively and ask the right questions of team members or NCEP/CAPA owners while presenting issues, trends and feedback clearly at CAPA Review Boards
• Conduct activities within with Risk Management frameworks (ie: ISO 14971)
• Implement systems to monitor the completion of assigned NCEP and CAPA deliverables per set schedules
• Maintain cross-functional team relationships; collaborate and facilitate effectively and positively with peers
• Work with Quality Systems leaders to establish and maintain goals and objectives, and ensure quality system, regulatory and safety policies and processes are followed
• Update and/or manage Quality Metrics pertaining to CAPA policy (ie: NCEPs, CAPAs, Product Inquiry Reports (PIR) and Field Actions)
• Deliver ongoing reporting and analytics of KPIs to the Senior Leadership team and for CAPA Review Boards
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Support external regulatory audits, as needed
• Coordinate or support Product Inquiry Reports (PIRs) for product or system nonconformances with the potential to impact patient safety
• Assist and participate in Management Review, CAPA Review Board and Franchise Meeting preparations
• Participate in Communities of Practices and communicate best practices or procedural changes to business site
• Other duties as required

Required qualifications:

• Bachelor’s Degree or higher in Engineering or science related field.
• Minimum of 5 years of experience working within quality systems in regulated industries, including experience in CAPA processes
• Experience with problem solving, project management and process improvement tools such as lean principles and six sigma
• Must be able to communicate effectively, by analyzing, summarizing, and presenting ideas concisely via visual communication methods i.e. tables, graphs, Excel, Minitab, and PowerPoint presentation.
• Experience in Medical Device or another regulated industry (e.g. Pharmaceutical, Healthcare, Aeronautic, Food Manufacturing)

Preferred qualifications:

• Leadership experience, including responsibility for employee assessment
• Medical device industry experience.
• Formal training in Root Cause Analysis tools (such as: 5-whys, Fishbone, FMEA, Fault Tree Analysis, etc.)
• Risk Management Experience
• Green or Black Belt in Six Sigma or Lean Certification or Certified Quality Professional credentials
• Project Management experience or certification
• Familiarity with tools like Power BI and/or Tableau for CAPA tracking and trending
• Familiarity with eCAPA software
• Strong technical writing skills
• Ability to influence and work with a team collaboratively.
• Proficiency in using statistical tools and methods to support root cause investigations, effectiveness checks and trend identification

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

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

Your responsibilities will include:

• Conduct mechanical design activities for developing complex cutting-edge medical device systems through prototyping, testing and modeling.
• Conduct simulation and modeling activities using tools such as FEA and CFD to predict mechanical performance and optimize design parameters
• Develop and validate computational models of mechanical systems using tools such as MATLAB or SolidWorks Simulation
• Perform independent tests, studies, analyses, and interpretations to generate technical conclusions and provide recommendations.
• Assist in DFM (Design for Manufacturing) activities.
• Develop device design history files (i.e., requirements, risk management, usability files.
• Ensure compliance to industry and international standards.
• Develop verification and validation plans, protocols, and reports.
• Conduct work across the full scope of technical and documentation activities for the department.
• Responsible for technical input into project level planning.
• Provide technical guidance to review work plans and advise on unusual features of projects
• Provide technical, project level leadership to engineering assistants or junior engineering staff.
• Participate in failure investigations and repair planning.
• Develop and test new manufacturing processes.
• Support regulatory filings to various government bodies as required.
• Support the development of intellectual property where required.
• Support pre-clinical and clinical research activities​ where required.
• Other duties as required.

Required Qualifications

• Bachelor’s degree in mechanical or biomedical engineering
• 3+ years of related working experience from a regulated manufacturing industry
• 3+ years of relevant design control experience
• Experience with the overall design and development process
• Experience with leading rapid design iteration and making design recommendations
• Strong hypothesis-driven experimental design and statistical analysis skills

Preferred Qualifications

• Experience focusing on R&D activities in the medical devices industry
• Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607
• Self-starter with the ability to quickly learn about new processes
• Excellent analytical and communication skills (both written and oral)
• Able to work independently and in a multidisciplinary team environment

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

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

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

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

Your responsibilities will include:

• Collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
• Applying technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Building quality into all aspects of work by maintaining compliance with all quality requirements.
• Planning, organizing and prioritizing own daily work routine to meet established schedule.
• Utilizing standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• Managing and updating product risk management files, specifically Risk Management Plans, Reports, Hazard Analyses, Task Analyses, Design FMEAs in accordance with ISO 14971.
• Supporting design changes for products that have already been commercialized.
• Reviewing design verification and validation protocols and reports.
• Developing test methods and performing test method validations.
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Other duties as required.

Required qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical, Electrical Engineering or related field of study
• 2+ years of relevant work experience
• Demonstrated interpersonal skills with ability to work within a team environment
• Strong written/verbal communication skills
• Must be able to work independently under limited supervision

Preferred qualifications:

• Experience in the medical device industry, i.e. reviewing and updating Device Master Records (DMRs), reviewing Device History Files (DHFs), and adhering to a Quality Management System (QMS)
• Training experience to FDA regulations or ISO standards

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

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

Your responsibilities will include:

• Collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
• Applying technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Building quality into all aspects of work by maintaining compliance with all quality requirements.
• Planning, organizing and prioritizing own daily work routine to meet established schedule.
• Utilizing standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• Managing and updating product risk management files, specifically Risk Management Plans, Reports, Hazard Analyses, Task Analyses, Design FMEAs in accordance with ISO 14971.
• Supporting design changes for products that have already been commercialized.
• Reviewing design verification and validation protocols and reports.
• Developing test methods and performing test method validations.
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Other duties as required.

Required qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical, Electrical Engineering or related field of study
• 2+ years of relevant work experience
• Demonstrated interpersonal skills with ability to work within a team environment
• Strong written/verbal communication skills
• Must be able to work independently under limited supervision

Preferred qualifications:

• Experience in the medical device industry, i.e. reviewing and updating Device Master Records (DMRs), reviewing Device History Files (DHFs), and adhering to a Quality Management System (QMS)
• Training experience to FDA regulations or ISO standards

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

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

Your responsibilities will include:

• Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
• Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Plans, organizes and prioritizes own daily work routine to meet established schedule.
• Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• Familiarity with requirements of ISO 14971, Manage and update product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs.
• Familiarity with IEC 62366 and the application of usability to medical device design.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Other duties as required.

Required qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical, Electrical Engineering or related field of study
• 2+ years of relevant work experience
• Demonstrated interpersonal skills with ability to work within a team environment
• Strong written/verbal communication skills
• Must be able to work independently under limited supervision

Preferred qualifications:

• Experience in the medical device industry
• Familiarity with Ultrasound Imaging, IEC 60601 Standards
• Training experience to FDA regulations or ISO standards

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

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