Position Overview

This role supports the supplier quality activities related to development and manufacture of medical devices. The position will work with Engineers to address various product reliability and quality issues. This role will be in charge of the execution of the IQOQ process for RI equipment’s, execution of TM, execution of inspection routines, control of calibrated equipment and drawing and receiving specification changes in quality system. Job duties:
  • Assists Engineers with investigation of raw material, product and process quality issues.
  • Assists Engineers with product testing and test method validations.
  • Assists Engineers with IQOQ executions.
  • Assists with activities related to equipment calibration, corrective/preventive actions, nonconformance reports, internal audits and CAPA projects.
  • Monitors all activities to ensure the product is processed properly through the entire process from receipt through transfer to finished goods.
  • Performs analysis and identifies trends in the inspection of finished products, in-process materials, raw materials, and recommends corrective actions when necessary.
  • Problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of defects.
  • Performs additional duties as assigned.
    1. High School Diploma or equivalent.
    2. Minimum three (3) years of technical work experience in the medical device industry.
    3. Strong written and verbal communications. Good interpersonal skills.
    4. Advance studies on Industrial engineering or similar career.
    5. 70% English required.
    Desired Qualifications
    1. Knowledge of medical product manufacturing and quality.
    2. Experience with medical device testing; experience testing MicroVention products is a plus.
    3. Ability to read and follow test procedures.
    4. Ability to perform product inspections; ability to understand technical documentation including mechanical drawings.
    5. Good computer skills especially with Word and Excel.
    6. Ability to work in controlled environments (clean rooms).
    7. Ability to work under pressure.
    8. Teamwork skills.