Quality & Validations Engineer
Biomerics
Cartago, CRI
hace 2 días

Biomerics is a leading provider of innovative polymer solutions for the medical device and biotech industries. As a world-class contract manufacturer, we specialize in the design, development, and production of medical devices for diagnostic and interventional procedures.

We are focused on next-generation solutions for the vascular access, electrophysiology and cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

Our capabilities include design engineering services, advanced components, and full contract manufacturing of finished devices.

We are hiring in the manufacturing plants located in Cartago Costa Rica. Free Trade Zone Parque Zeta.

Essential Duties and Responsibilities / Obligaciones y responsabilidades esenciales :

  • Responsible for the following areas Quality & Validations engineering activities (including technicians)Sustaining / improvements quality system
  • Participate in transfers process for new products from internal or external customers according to company strategy.
  • Designs layout of equipment and workspace for maximum efficiency for the Quality proposals.
  • Coordinates with production planning and design engineering concerning product design and tooling / fixturing to ensure efficient testing methods.
  • Creates inspection procedures and routings for quality inspections.
  • Provides support during the validation stages (IQ, OQ, PQ)
  • Designs tooling and fixtures for the quality tests.
  • Supports manufacturing in training and calibration / maintenance on an as-needed basis.
  • Performs and documents process capabilities studies.
  • Establishing, maintenance and publishing metrics that shows indicators of performance of the transfer process.
  • Responsible for identifying any gap on the Quality System and verify it is corrected.
  • Being part of the Internal Audit team.
  • Establish and maintain activities oriented to Continuous Improvement.
  • Responsible for coordinated the response to Corrective Actions Request from Customer on the time frame establish by each customer.
  • Establish and execute the Annual Internal Schedule.
  • Qualifications / Calificaciones :

  • Experience of 2 years on similar positions on the medical industry sector.
  • Experience on ISO 13485.
  • Knowledge of FDA QSR 21 CRF Part 820 and Part 11
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