Engineer II, QA
Boston Scientific
Coyol, A, CR
hace 1 día

Purpose and Passion

  • Comprehensive Benefits
  • Life-Work Integration
  • Community
  • Career Growth
  • At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level.

    With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges.

    Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life’s work.

    About the Role :

    Identify, analyze, investigate, monitor and document patterns and trends in post marketing surveillance data as part of the CAPA system.

    Communicate and educate management, R&D, marketing, sales organization and other departments, as well as external customers about product performance.

    Ensure that information and insight gained from the investigations and corrective actions is fed back to the R&D and marketing organizations as part of the risk management and design input systems.

    Your Responsibilities Include :

  • Analyzes customer complaints, events and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary.
  • Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams.
  • Documents trend action by updating the trend report at appropriate levels and by performing a Health Risk Analysis.
  • Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.
  • What We’re Looking For :

  • Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
  • English Level desired : B2 : (70-79%).
  • Desired knowledge : ASQ certification (CQE, SSGB) desired, Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods, Scientific tools (e.
  • g. Gage R&R, DOE, process capability, problem solving methodologies.

  • Experience on managing regulations and complaint MDR / MDV.
  • At least 2 years of experience in similar position.
  • Or an equivalent combination of education and experience.
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