Design Quality Engineer

hace 2 meses


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

Work Environment: Hybrid

Location: Heredia, Costa Rica

About the Role:

As a Design Quality Engineer in our hybrid team, you will provide pre-market and post-market design quality assurance support to ensure the delivery of high-quality products to our customers.

Your Responsibilities:

  • Represent the division on global quality system improvement projects, soliciting input from stakeholders and advocating for the needs of the engineering team.
  • Own quality system NCEPs, CAPAs, and project plans related to design assurance and risk management.
  • Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Collaborate with internal customers on related processes such as management review, design controls, risk management, cybersecurity, and post-market surveillance.
  • Comply with all corporate and applicable regulations related to complaint investigation management.
  • Monitor regulatory submission and audit questions, communicating lessons learned to internal customers and assisting teams with response writing.
  • Supervise and support the design quality assurance team in activities related to PDP projects.
  • Assist with engineering evaluations and updates of procedures.

Requirements:

  • Bachelor's degree or above in a STEM-related field.
  • At least 7 years of experience in a similar position.
  • English language proficiency: C1 level (90-94%).
  • Desirable knowledge: Formal training in statistical and quality techniques, ASQ certification.
  • Experience in managing regulations and complaints, MDR / MDV.


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