Quality Manager - Montréal, Canada - Boston Scientific Corporation

Boston Scientific Corporation
Boston Scientific Corporation
Verified Company
Montréal, Canada

2 weeks ago

Sophia Lee

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Sophia Lee

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Description

Work mode:
Hybrid
Onsite Location(s):Montreal, QC, CA
Additional Locations: Canada-QC-Montreal
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 highperforming 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:


  • The Design Assurance Quality Manager will lead a team of premarket and postmarket Design Quality Engineers to ensure safe and compliant development and commercialization of complex technologies and products

Your responsibilities will include:


  • Builds and maintains an inclusive, diverse, and highperforming culture.
  • Work with crossfunctional teams to implement business continuity, cost reduction, and field improvementrelated projects.
  • Represent the division on various global quality system improvement projects by proactively soliciting input from stakeholders, reviewing proposals to assess impact on EP, and advocating for EP needs amongst global counterparts.
  • Owns and drives independently quality system NCEPs, CAPAs, and project plans relating to Design Assurance and Risk Management.
  • Applies sound, systematic problemsolving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Successfully navigates in grey spaces and provides logical and creative guidance to teams.
  • Works with internal customers who represent related and interconnected processes such as Management Review, Design Controls, Risk Management, Cybersecurity, Post Market Surveillance, Clinical, Medical Safety, Regulatory, and Complaint handling.
  • Ensures compliance with all Corporate and applicable regulations related to complaint investigation management.
  • Monitors regulatory submission & audit questions and responses, proactively communicates lessons learned to internal customers, and assists teams with response writing for product and quality systemrelated questions.
  • Supervise and provide support to the Design Quality Assurance team in activities related to PDP projects.
  • Assist and lead the team with engineering evaluations/generation and updates of procedures.
  • Improve systems and procedures from the Design Quality area.

Required qualifications:


  • Bachelor's degree in a STEMrelated Field.
  • Experience in managing regulations and complaints MDR / MDD.
  • Experience with design controls, risk management, and postmarket surveillance.
  • At least 6 years of experience in a similar position.

Preferred qualifications:


  • Master's degree in an engineering, business, or regulated industry field.
  • Formal training on statistical and quality techniques and ASQ Certified.
  • Experience managing technical teams.

Requisition ID:

Job Segment:R&D Engineer, Quality Manager, R&D, Compliance, QC, Engineering, Quality, Research, Legal
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