Senior Quality Assurance Engineer

1 month ago


Reston, Virginia, United States Infraredx, a Nipro Company Full time
Senior Quality Engineer

At Infraredx, a Nipro Company, we are seeking a highly skilled Senior Quality Engineer to join our team. As a key member of our quality assurance team, you will play a critical role in ensuring the quality of our design, sourcing, and manufacturing processes.

Key Responsibilities:
  • Develop and validate test methods and inspection procedures to ensure compliance with regulatory requirements.
  • Participate in the development of test protocols and reports, and execute and review engineering change orders.
  • Define product acceptance criteria and evaluate process capabilities to ensure quality and reliability.
  • Participate in product risk analysis and FMEA analysis to identify potential quality issues.
  • Identify, prioritize, communicate, and resolve quality issues in a fast-paced environment, adapting to dynamic business needs.
  • Support monitoring and certification of controlled environments, and identify and implement effective process controls to support product development and manufacturing.
  • Generate and assess quality metrics and trends that affect product quality, and drive corrective actions to resolve recurring problems through the CAPA process.
  • Participate in developing inspection requirements for products, work-in-process, and procured components, and participate in NMR/MRB activities, including material disposition.
  • Participate in internal and external audits and other quality system maintenance/improvement activities to ensure compliance with regulatory standards and regulations.
  • Provide support to the complaint handling function and design control activities as required.
Requirements:
  • Bachelor of Science degree in a technical discipline, such as Electrical or Mechanical Engineering.
  • 5-7 years of engineering experience in the medical device industry, with a focus on complex high-volume disposables.
  • Strong written and verbal communication skills, and demonstrated use of quality tools and methodologies.
  • Microsoft Office experience, including Word, Excel, and PowerPoint.
  • Working knowledge of 21 CFR 820, EU MDR, ISO 13485, ISO 14971, design verification, process validation, product design control, CAPA, FMEA, and Kaizen methodologies.
  • Ability to work independently and as a member of a cross-functional team, with strong problem-solving and analytical skills.
  • ISO 19011 certification and current ASQ certification are preferred.


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