MicroVention is now Terumo Neuro

Engineer Sr., Quality - CR (Shift B)

Position Overview

Support the development and manufacturing of existing and new introduction of medical devices. Work with Manufacturing and R&D to resolve product quality issues which may include field complaints. Support manufacturing process changes, product design improvements, and the implementation of new products or hazards communications, exposure assessments, and waste management. Job duties:
  • Work with manufacturing engineers to review process changes, resolve product quality issues, and assess related risks.
  • Lead and support all transfers activities related with quality.
  • Lead and/or support process, product, and/or equipment validation activities (IQ, OQ, PQ). Execute equipment validation activities as required.
  • Obtain, analyze, and present to management the key performance indicators related to quality process.
  • Work with R&D engineers to support implementation of new products by reviewing quality and testing plan and develop FMEAs.
  • As assigned, maintain various Quality Systems such as CAPA, complaints, Non-conformance, supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  • Perform additional duties as assigned.

Job Details

Job ID 13023BR

Alajuela, Costa Rica

Apply for this job
    1. Bachelor’s degree in engineering or a related field.
    2. Minimum of five (5) years of related experience in quality engineering or quality assurance role.
    3. Minimum of three (3) years of related medical device manufacturing experience.
    4. Advanced Knowledge in NCRs, root cause analysis, and implementation of Corrective and Preventive Actions.
    5. Experience in complaint handling, supplier quality engineering, internal auditing, transfers, and non-conforming product.
    6. Effective and strong written and verbal communication skills; ability to partner with associates at various levels within the organization.
    7. English level at B2 or above (based upon Belt Certification Process).
    8. Proficient with MS Office Suite including Word, Excel, Outlook, and Teams.
    9. Ability to read and interpret PFMEA Risk assessment tool to defined further actions determination.
    Desired Qualifications
    1. Knowledge of medical product manufacturing.
    2. Ability to learn and apply technical knowledge of neurovascular medical devices products.
    3. Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).
    4. Knowledge of ISO 13485: Understanding of the ISO 13485 standard for medical device quality management systems.
    5. Proficiency with statistical software (Minitab, Stratigraphic, Design of Experiment DOE).
    6. Knowledge of risk management principles, practices, and standards relevant to the medical device industry.