Senior Quality Assurance Engineer

hace 12 horas


San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

Company Overview:

Boston Scientific Corporation is a leading global medical technology company that shapes medicine and improves lives.

We are committed to advancing the treatment of various diseases and conditions, from cardiovascular disease and cancer to gastrointestinal and neurological disorders. Our mission is to improve patient outcomes through innovative medical technologies.

Job Description:

The Quality Engineer II will be primarily responsible for the execution of Post Market Reporting assessments, including but not limited to all associated design control and quality system deliverables related with execution.

This role will identify, analyze, investigate, monitor, and document trends at a product performance level for post marketing surveillance data.

The successful candidate will also lead project teams and franchises in the execution of Quality Deliverables, including but not limited to Post-Market Surveillance Plan & Report, as well as collaboration on the execution of Clinical Evaluation Reports.

Responsibilities:

  • Lead project teams and franchises in the execution of Quality Deliverables
  • Analyze customer complaints, compliance events, clinical data, and post-marketing surveillance data by examining for patterns, trends, and investigating when necessary
  • Investigate potential and/or identified trends or data issues with cross-functional teams across divisions
  • Represent the company during regulatory audits and support government agency inquiries
  • Provide guidance to assurance compliance to all relevant laws and regulations
  • Develop and implement processes to ensure high-quality products and services
  • Mentor junior staff and foster a diverse and inclusive workplace

Required Qualifications:

The ideal candidate will have a Bachelor's Degree in Mechanical, Electrical, or Biomedical Engineering, or a related discipline, and at least 2 years of experience in design controls, post-market, and/or risk management.

Prior experience with Microsoft Office Suite, specifically Excel, and strong communication and presentation skills are highly desired.

About Boston Scientific:

Boston Scientific is a global leader in medical technology, dedicated to improving patient outcomes and enhancing the delivery of healthcare worldwide.

We offer a collaborative and dynamic work environment, with opportunities for professional growth and development.



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