Boston Scientific Quality Engineer III CAPA 

Canada, Ontario, Mississauga 

192431535

Canada-ON-Mississauga; Canada-ON-Toronto

Develops, establishes and maintains quality engineering methodologies, 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 engineering support within sustaining, operational, or system/services support.

Your responsibilities will include:

• Work in cross-functional teams under the direction of the Quality Manager/Team Lead to support and execute processes and quality deliverables associated with CAPAs and quality systems
• Assist with administration and management of the NCEP and CAPA process
• Conduct NCEPs and CAPAs using systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Proactively investigate, identify, and implement best-in-class quality practices.
• Knowledgeable on Risk Management
• Ensure completion of assigned NCEP and CAPA deliverables per set schedules.
• Maintain cross-functional team relationship; collaborate and facilitate effectively and positively with peers.
• Work with manager and lead to establish and maintain goals and objectives, and ensure quality system, regulatory and safety policies and processes are followed.
• Draft and support the development of Quality Plans and Project Tracking Plans for projects
• 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 or higher in Engineering or science related field.
• Minimum 3+ years of risk management/manufacturing/operations experience.
• Experience with nonconformances, CAPA, problem solving 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.
• Nice to have qualifications:
• Medical device industry experience.
• Hands-on technical/mechanical experience and aptitude.
• Experience with manufacturing transfer projects.
• Ability to influence and work with a team collaboratively.
• Demonstrated leadership of problem solving in a manufacturing support role.
  

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.