Quality Assurance Specialist

2 weeks ago


Burlington, Massachusetts, United States Precision Life Sciences Full time

Job Overview: Quality Assurance Specialist

The Quality Assurance Specialist will contribute to ongoing engineering support and the development of new products within the Quality Assurance division at Precision Life Sciences, navigating a dynamic and intricate engineering landscape.

KEY RESPONSIBILITIES

  • Assist in sustaining engineering through operational quality initiatives, including material oversight, process enhancement, inspection and acceptance procedures, nonconforming material management, equipment validation, and supplier oversight.
  • Engage in risk management processes, conducting analysis and documentation throughout the product development lifecycle.
  • Evaluate and test materials, equipment, processes, and products to verify compliance with quality standards.
  • Contribute to the development and validation of testing methodologies.
  • Collaborate with design engineering teams on catheters, hardware, and systems during the design control phase.
  • Establish and execute quality system processes to adhere to regulatory requirements.

QUALIFICATIONS AND EXPERIENCE

  • Bachelor's degree in mechanical or biomedical engineering or a related engineering discipline.
  • 3-5 years of experience in quality engineering, quality assurance, or a comparable role within a regulated sector.
  • Familiarity with catheter, hardware, and system manufacturing, or similar medical devices, while engaging with a Quality Management System.
  • Working knowledge of 21 CFR 820 and ISO 13485:2016 standards.
  • Proven proficiency in Process Validation, Product Validation, and Statistical Techniques.
  • Experience in risk management and design control methodologies.
  • Strong communication abilities, effective documentation practices (including formal protocols and reports), meticulous attention to detail, and project management capabilities.


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