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Boston Scientific

Medical devices maker for interventional specialties

Senior Supplier Quality Engineer - Electronics, Engineering

Quality EngineeringConfirmed live in the last 24 hours
Full-timeArden Hills, MN, USA

About the Job

Requirements

  • A Bachelor of Science degree in Engineering or a similar field and at least 5 years of relevant quality engineering experience.
  • Experience in component manufacturing or raw material production.
  • Ability to communicate information clearly and concisely, with communication style and depth appropriate to the audience.
  • Ability to influence cross-functional global teams spanning Design Quality Assurance, Research and Development, Regulatory, Supplier Engineering, and Sourcing.
  • Ability to build strategic, trusting relationships through technical capability, critical thinking, and teamwork.
  • Experience with Quality Management Systems, including ISO 13485, FDA 21 CFR 820, and ISO 9001; regulatory compliance; and risk management.
  • Experience with quality problem-solving tools, Corrective and Preventive Actions (CAPA), and technical documentation.
  • Ability to work independently and collaborate with project teams; strong organization and self-direction.
  • Willingness to travel domestically and internationally up to 10%.

Responsibilities

  • Lead supplier audits to assess compliance with regulatory and Boston Scientific requirements, including scheduling, investigation and evaluation of findings, reporting, follow-up, and confirmation of follow-up actions.
  • Assess supplier capabilities through on-site visits and technical discussions, and support evaluation of proposed supplier changes.
  • Develop solutions to complex problems involving analysis of data and identifiable factors, selecting methods and techniques within established practices and policies.
  • Communicate quality issues to suppliers, apply systematic problem-solving methods, and review and approve supplier corrective action plans and effectiveness documentation.
  • Investigate field failures related to supplier materials and develop corrective action plans when necessary.
  • Assess and drive reactive and proactive supplier projects and investigations in partnership with Supplier Engineering, Manufacturing/Test Operations, Commercial Sourcing, Design Assurance, and Research and Development.
  • Engage with Global Sourcing category teams as a technical lead and establish and execute category objectives.
  • Lead cross-divisional and cross-functional projects that improve quality systems and processes.
  • Independently develop approaches to solutions for projects and special assignments, interpret and execute company policies, recommend policy modifications, and assist in establishing departmental policies and procedures.
  • Provide leadership and mentorship to junior engineers.
  • Establish business relationships and interact with suppliers to facilitate assignments; participate in project goal-setting, lead projects within the function or department, represent a specialized field on larger project teams, and influence middle management on business solutions.
  • Maintain compliance with the Quality Policy and documented quality processes and procedures, prioritizing patient safety and product quality.
  • Ensure personnel and tools are available to support Quality System compliance and adherence to the Quality Policy, and foster a work environment that upholds the Quality Policy and Quality System.
  • Drive supplier performance improvement and increase suppliers’ capabilities to consistently meet company requirements.
  • Collaborate with cross-functional teams to resolve component-related challenges throughout the supply chain, including receiving inspection, manufacturing, testing, and assembly into finished goods.
  • Support global sourcing, manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects.
  • Drive improvement and corrective action in the quality of components sourced from outside suppliers.
  • Provide technical support in supplier selection and develop acceptance criteria for materials.
  • Monitor supplier performance to drive supplier corrective action, address manufacturing yield issues, and resolve field failures.

Desired Qualifications

  • Lead auditor certification to ISO 13485, ISO 9001, or TS 16949 standards.
  • Experience with manufacturing support or process development.
  • Experience with project management.

About the Company

Boston Scientific

Medical devices maker for interventional specialties

Boston Scientific designs and makes medical devices used in procedures across cardiology, endoscopy, urology, and neuromodulation. Its products help doctors diagnose and treat conditions by guiding minimally invasive interventions and delivering therapies inside the body, with revenue from hospitals and clinics. The firm differentiates itself through a broad, global portfolio and heavy ongoing investment in research and development to expand capabilities and address complex health issues. Its goal is to improve patient care by providing reliable, effective medical devices and solutions that enable clinicians to perform safer, more effective procedures while growing its business.

Company size
10,001+
Company stage
IPO
Headquarters
Marlborough, MA
Founded
1979

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