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Senior Quality Assurance Engineer

2 months ago


Tempe, Arizona, United States MillenniumSoft Full time

Position: Senior Quality Assurance Engineer

Company: MillenniumSoft

Key Responsibilities

  • Facilitate and oversee design and process root cause analysis while managing non-conformance and complaint investigations.
  • Make informed, risk-based decisions and effectively communicate these to stakeholders.
  • Prepare and deliver project updates and engage in technical discussions.
  • Direct the development of risk assessments and testing methodologies.
  • Oversee component qualifications, as well as design validation and verification processes.
  • Lead investigations related to product quality.
  • Evaluate product modifications in relation to design specifications.
  • Assist in translating design requirements into manufacturing control plans.
  • Support the regulatory team in drafting technical submissions.
  • Adhere to company policies, procedures, and relevant government regulations.

Experience and Physical Requirements

The role necessitates regular standing, walking, sitting, and the use of visual and manual dexterity to handle tools and office equipment. Effective verbal communication with colleagues is frequently required, along with occasional reaching, stooping, kneeling, or crouching.

Essential Skills and Qualifications

  • In-depth understanding of product usage and its implications for users to effectively manage risks.
  • Proficient in Quality Engineering methodologies including Sampling Plans, Root Cause Analysis, and Statistical techniques.
  • Advanced knowledge of statistical and risk assessment methodologies.
  • Familiarity with test method development and validation, equipment qualifications, process and design validation, and component qualification techniques.
  • Excellent interpersonal communication skills.
  • Ability to analyze and enhance manufacturing and quality systems related to product design and prototyping.
  • Strong problem-solving capabilities.
  • Effective oral and written communication skills.
  • Knowledge of regulatory standards such as ISO 13485 and ISO 14971.

Preferred Qualifications

  • Certification in Quality Engineering (ASQ) or equivalent.
  • Bachelor's degree in Engineering.