Senior Electronics Supplier Quality Engineer - Impact

Boston Scientific

United States

On-site

USD 85,000 - 162,000

Full time

9 days ago

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Job summary

Boston Scientific is seeking a Sr. Supplier Quality Engineer - Electronics to lead supplier quality initiatives and drive improvements across the electronics supply base.

The role focuses on audits, CAPA, and collaboration with Design QA, R&D, Regulatory, and Sourcing to ensure compliance with ISO 13485, FDA 21 CFR 820, and ISO 9001. The position requires a BS in Engineering with at least 5 years of experience in supplier quality, strong problem-solving skills, and up to 10% travel.

Qualifications

  • BS degree in Engineering with minimum of 5 years of relevant quality engineering experience.
  • Experience in various component manufacturing or raw material production.
  • Communicates effectively and concisely to deliver key points.
  • Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
  • Builds strategic and trusting relationships through technical capability, critical thinking, and teamwork.
  • Experience in Quality Management Systems (ISO 13485, FDA 21 CFR 820, ISO 9001) and risk management.
  • Experience with problem solving quality tools, CAPA, Technical Documentation.
  • Willingness to travel domestically and internationally up to 10%.

Responsibilities

  • Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including scheduling, investigations, and follow-up actions.
  • Proactively assesses supplier capabilities through on-site visits and technical discussions and supports supplier changes.
  • Develops solutions to complex problems and communicates quality issues to suppliers, applying corrective action plans.
  • Leads cross-divisional and cross-functional projects delivering improvements to quality systems and processes.
  • Mentors junior engineers and interacts with suppliers to drive improvements and ensure product quality.

Skills

Quality engineering
Cross-functional collaboration
Regulatory compliance
Root cause analysis

Education

Bachelor's degree in Engineering

Job description

Boston Scientific is seeking a Sr. Supplier Quality Engineer - Electronics to lead supplier quality initiatives and drive improvements across the electronics supply base.

The role focuses on audits, CAPA, and collaboration with Design QA, R&D, Regulatory, and Sourcing to ensure compliance with ISO 13485, FDA 21 CFR 820, and ISO 9001. The position requires a BS in Engineering with at least 5 years of experience in supplier quality, strong problem-solving skills, and up to 10% travel.

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