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Quality Assurance Systems Engineer

2 months ago

Burlington, Vermont, United States InfraredX, Inc. Full time
Key Responsibilities
  • Facilitates the complaint management process within the organization, ensuring adherence to Infraredx Quality Management Systems (QMS) with a specific focus on Customer Complaints. Additional duties encompass support for various QMS functions such as Management Review, Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NMRs), and Risk Assessments.
  • Oversees and coordinates activities related to the Infraredx complaints process, which includes complaint administration, record management, investigations, reporting, and metrics analysis.
  • Prepare and present materials for Monthly Complaints Meetings to the Senior Leadership team.
  • Collaborate with cross-functional teams to optimize resource utilization and ensure successful outcomes across business units.
  • Conduct risk assessments using existing product risk documentation, such as Process Failure Mode Effects Analysis (PFMEAs) and User Failure Mode Effects Analysis (UFMEAs), while identifying gaps and providing constructive feedback for necessary documentation updates.
  • Adopt a data-driven approach in all aspects of the role and decision-making processes, including product performance evaluations, maintaining consistency regardless of objectives.
  • Collect and analyze information from diverse sources to make timely reporting decisions, demonstrating the ability to interpret clinical data and customer feedback effectively.
  • Draft customer communications to inform users about Best Practices or Instructions for Use as required.
  • Assist in field actions and other post-market surveillance activities when necessary.
  • Act as a subject matter expert for Infraredx, providing insights on investigation tools, statistical analysis, and best documentation practices.
  • Identify and implement opportunities for enhancement within the Quality System to ensure compliance and operational efficiency, including the development and release of new or revised Quality System documentation.
  • Recognize when to escalate quality issues to the leadership team, presenting relevant data and information to facilitate informed decision-making.
  • Mentor and guide less experienced engineers in all facets of the complaint administration process, offering feedback on complaint handling and daily operations.
  • Contribute to quality plans, processes, and special projects as needed.

Qualifications

  • Bachelor's degree in Engineering, Biomedical Science, or a related technical field, with 2-5 years of relevant experience in the medical device sector.
  • Familiarity with Quality System Standards and regulations, including ISO 9001, ISO 13485, and Quality System Regulation (QSR).
  • Experience in operational quality functions within a medical device manufacturing environment is highly preferred.
  • Participation in internal and external audits, preferably as a qualified internal auditor.
  • Excellent written and verbal communication skills, along with strong project management capabilities.
  • Proficient analytical, deductive reasoning, and listening skills.
  • Experience in developing and documenting procedures and processes.
  • Ability to communicate clearly and accurately at all organizational levels.
  • Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Access.


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