Quality Engineer

5 days ago

Hopkins, Minnesota, United States Arobella Medical LLC Full time $84,000 - $86,000 per year

Overview:

The Quality Specialist supports Arobella Medical's commitment to safety, performance, and regulatory compliance by ensuring that all ultrasonic wound care devices, handpieces, and accessories meet internal and external quality standards. This role focuses on inspection, documentation, and process improvement to ensure the highest product reliability and continuous compliance with ISO 13485 and FDA QSR requirements.

Key Responsibilities:

  • Perform incoming, in-process, and final inspections on medical devices and components, including handpieces, generators, and accessories.
  • Review and maintain Device History Records (DHRs), calibration logs, and inspection documentation to ensure completeness and traceability.
  • Support CAPA, NCR, and RMA processes by assisting with root cause investigations, corrective actions, and verification of effectiveness.
  • Assist in internal audits and support external audits (FDA, ISO, customer) by maintaining accurate and audit-ready records.
  • Collaborate closely with manufacturing, service, and engineering teams to resolve quality issues and identify opportunities for improvement.
  • Track and analyze quality metrics, including nonconformance trends, inspection results, and complaint data.
  • Support supplier quality activities, including verification of supplier documentation and incoming component validation.
  • Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and Arobella Medical's Standard Operating Procedures (SOPs).
  • Participate in continuous improvement initiatives to enhance efficiency, reduce waste, and strengthen overall quality performance.

Qualifications:

  • Bachelor's degree in Quality, Engineering, or Life Sciences (or equivalent experience).
  • 5 years or more experience in a medical device quality assurance or manufacturing environment.
  • Familiarity with FDA requirements.
  • Strong attention to detail, documentation accuracy, and problem-solving ability.
  • Excellent communication and collaboration skills across departments.

Preferred Skills:

  • Experience with CAPA, RMA, and complaint handling systems.
  • Knowledge of risk management, validation, and calibration programs.
  • Exposure to ultrasonic or electronic device manufacturing is a plus.

Job Type: Part-time

Pay: From $40.26 per hour

Work Location: In person

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