Quality Assurance Specialist

hace 1 semana


Tecate, Baja California, México Teleflex A tiempo completo

About Teleflex Incorporated

Teleflex Incorporated is a global leader in the design, development, and manufacture of medical technology solutions. Our company is dedicated to improving the lives of patients and healthcare providers through innovative products and services.

Position Summary

The Quality Assurance Specialist, Design Assurance will be responsible for ensuring the quality of new product development and improvement, from technology transfer to commercialization. This role will ensure that all applicable elements of the Quality System and external standards are followed.

Key Responsibilities

  • Partner with cross-functional teams to support activities in product and process design, including design verification, design validation, design reviews, design transfer, and design history file management.
  • Create and maintain risk files, including risk management plans, hazard and risk analyses, failure mode and effects analyses, and risk management reports to assess product risks.
  • Analyze post-market surveillance data to feed back into the risk file and reflect the current risk profile of the product.
  • Support Clinical and Medical Writers in the analysis of available clinical data.
  • Ensure compliance with the Quality Management System, including comprehensive documentation, adequate records, and change management.
  • Interpret customer feedback to define user needs and product requirements.
  • Partner with Product Quality Assurance and Operations to make risk-based decisions associated with nonconformances and technical complaints.
  • Perform root cause analysis of identified issues and identify corrective and preventive action.
  • Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.

Requirements

The ideal candidate will have a B.A. or B.S. degree in a technical discipline, such as engineering or science, and 5-10 years of quality engineering or design assurance experience in the medical device industry. ASQ certification is preferred. The candidate should have a strong understanding of industry regulations, such as ISO 13485, ISO 14971, and FDA 21CFR820, and be proficient in MS Office and statistical software.

What We Offer

Teleflex Incorporated offers a dynamic and growing work environment, with opportunities for professional growth and development. We foster a positive culture of growth, collaboration, and achievement across the organization.



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