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Lead Quality Assurance Engineer

2 months ago

New Bedford, Massachusetts, United States Infraredx, a Nipro Company Full time

As a key member of the engineering team at Infraredx, a Nipro Company, you will play a crucial role in ensuring the excellence of product design, sourcing, and manufacturing processes. Your expertise will be vital in guiding the transition of intricate electromechanical medical devices from development to production. You will be responsible for formulating, reviewing, and executing engineering modifications while establishing quality inspection standards.

Primary Responsibilities:

  • Design and validate testing methodologies and inspection protocols. Engage in the creation of test plans and documentation as necessary.
  • Review and execute engineering change requests.
  • Establish product acceptance criteria and assess process capabilities.
  • Contribute to product risk assessments and Failure Mode and Effects Analysis (FMEA).
  • Proactively identify, prioritize, communicate, and resolve quality challenges in a dynamic environment, adapting to shifting business requirements.
  • Assist in the oversight and certification of controlled environments.
  • Identify and implement robust process controls to facilitate the development, qualification, and manufacturing of products.
  • Generate and analyze quality metrics to identify trends impacting product quality. Conduct failure analyses and drive corrective actions to address recurring issues through the Corrective and Preventive Action (CAPA) process.
  • Contribute to the development of inspection criteria for products, work-in-progress, and purchased components.
  • Engage in Non-Conformance Review (NMR) and Material Review Board (MRB) activities, including material disposition.
  • Participate in internal and external audits and other quality system enhancement activities to ensure compliance with various regulatory standards.
  • Provide assistance to the complaint management process as needed.
  • Support design control initiatives as required.

Qualifications:

  • Bachelor's degree in a technical field, preferably in Electrical or Mechanical Engineering.
  • 5 to 7 years of experience in the medical device sector, with a focus on complex high-volume disposable products preferred.
  • Excellent written and verbal communication skills, with a proven track record in utilizing quality tools and methodologies.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
  • Familiarity with regulatory standards such as 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 collaboratively within a cross-functional team, managing multiple tasks and meeting stringent deadlines.
  • ISO 19011 certification is a plus.
  • Current ASQ certification is preferred.
  • Ability to engage effectively with all organizational levels.