Design Quality Assurance Specialist

hace 4 días


Tijuana, Baja California, México Corza Medical A tiempo completo

Job Summary

We are seeking a highly skilled Design Quality Assurance Specialist to join our team at Corza Medical. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our medical device products.

Key Responsibilities

  • Develop and maintain quality engineering methodologies to ensure the delivery of safe and effective products.
  • Guide quality assurance efforts in the design and development of technical transfers.
  • Document experiment plans and results, including protocol writing and reports.
  • Lead the investigation, resolution, and prevention of product and process nonconformances.
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices.
  • Support design reviews and transfers, providing inputs on quality requirements and ensuring gap analysis and risk mitigation strategies.
  • Provide guidance and support to other engineers to ensure quality integrity.
  • Support the development and implementation of various product and process improvement methodologies.
  • Work with design engineering in the completion of product verification and validation.
  • Assist in the development and execution of streamlined business systems to effectively identify and resolve quality issues.
  • Design and conduct experiments for process optimization and/or improvement.

Requirements

  • Bachelor's degree in Engineering or equivalent education and experience.
  • 3+ years of experience working in a Design Quality Engineering role within a medical device industry.
  • Strong knowledge of quality management systems.
  • Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities).
  • Strong Knowledge of statistical analysis tools and their use in product design and manufacturing.
  • Six Sigma training is a must.
  • Experience in creating design control documentation during the whole lifecycle of the development process.
  • Experience with previous transfer of products from design to volume manufacturing.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Strong project management and leadership skills, including the demonstrated ability to lead project teams and resolve quality-related issues in a timely and effective manner.
  • Advanced computer skills, including statistical/data analysis and report writing skills.
  • Experience implementing various product and process improvement methodologies.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Fluent in Spanish and English required.


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