Boston Scientific Quality Systems Team Leader 

Canada, Ontario, Mississauga 

854073577

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).