Quality Assurance Specialist

hace 5 días


Nogales, Sonora, México Bd A tiempo completo

Job Overview

The Medical Device Quality Lead role is responsible for ensuring the quality and compliance of medical devices manufactured by BD. This position requires strong leadership skills, a thorough understanding of regulatory requirements, and the ability to implement effective quality systems.

Key Responsibilities:

  • Evaluate and improve test methods and inspection procedures used for acceptance activities.
  • Establish and execute test method validations.
  • Review and approve process/product validations.
  • Develop risk analyses for waivers, reworks, sorts, and use as is.
  • Coordinate periodic meetings to evaluate customer complaints trends and action plans to reduce recurrence of failures.
  • Provide support in responding to customer complaint investigations.
  • Evaluate complaints to determine applicability to manufacturing/supplier.
  • Perform investigations to address failures and/or trends reported by customers.
  • Investigate potentials for failure to detect risk to the product/process.
  • Investigate and respond external rejection reports.

Requirements:

  • Bachelor's degree in Engineering or related field.
  • 2 years of experience in a similar position.
  • Knowledge of statistics techniques and statistical process control (SPC).
  • Data analysis, problem-solving, time management, teamwork, and leadership skills.
  • Math abilities at a professional level and statistical interpretation for decision-making.
  • Intermediate English language skills.

Additional Information:

Estimated annual salary: $65,000 - $80,000 depending on location and experience. The primary work location is MEX Nogales South - Parque Industrial El Cid. Additional locations may be available. A bachelor's degree in Engineering or a related field is required. 2 years of experience in a similar position are preferred. Knowledge of statistics techniques and statistical process control (SPC) is essential. Data analysis, problem-solving, time management, teamwork, and leadership skills are also necessary. Math abilities at a professional level and statistical interpretation for decision-making are required. Intermediate English language skills are necessary for this role. BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity, or sexual orientation.



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