MicroVentionTerumo

Sr Engineer, Validation & Process Transfer - CR

Position Overview

Support the development and manufacturing of existing and new medical devices. Work with Manufacturing, Transfer, and R&D to resolve product quality and transfer/validations issues. Support the transfer process, product design improvements and the new product design and implementation process, validation and transfer assessments, project and process risk management through PFMEA analysis. Job duties:
  • Work with Transfer Engineers to review process changes and resolve product quality issues.
  • Work with suppliers to maintain high quality levels of incoming production materials.
  • Lead and/or support process, product and/or equipment validation transfers, and design process activities (e.g., IQ, OQ, PQ, etc.). Execute equipment validation activities as required.
  • Obtain, analyze, and present to management the key performance indicators related to validation/quality process.
  • Work with R&D Engineers to support implementation or transfers of new products by reviewing quality, testing plans, and quality transfer strategies.
  • As assigned, maintain various regulatory systems such as Validation, CAPA, complaints, non-conformance, supplier quality, equipment calibration, internal auditing, quality metrics data analysis, and transfer documentation.
  • Travel and carry out evaluations of new products at the level of product quality risks as well as the transfer and validation strategy.
  • Maintain clear and effective communication with the local and corporate Quality departments to ensure alignment of criteria and the success of the projects in a timely manner.
  • Review and ensure validation protocols as well as monitor quality policies regarding the transfer and validation processes of processes/products.
  • 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 12003BR

Alajuela, Costa Rica

    1. Bachelor’s degree in a related field.
    2. Minimum of five (5) years of related experience in a Quality/Validation Engineering or Quality Assurance role.
    3. Advanced knowledge in Validation, Transfers process, statistics analysis, PFMEA, TMVs, Root Cause Analysis, and implementation of Corrective and Preventive Actions.
    4. Strong written and verbal communication skills.
    5. Bilingual in both English and Spanish (reading, writing, listening, speaking).
    6. U.S. VISA
    Desired Qualifications
    1. Knowledge of medical product manufacturing.
    2. Experience in complaint handling, supplier quality engineering, internal auditing, and equipment calibrations.
    3. Ability to understand the technology related to MicroVention’s products.
    4. Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).
    5. Computer skills including MS Word & Excel.
    6. Advanced use of Minitab & statistical tools.
    7. Advanced use of MSM Project.