Quality Inspection Failure Analysis 3 - Swing Shift

Intuitive

Peachtree Corners (GA)

On-site

USD 65,000 - 90,000

Part time

14 days+
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Job summary

Intuitive is seeking a QA/Failure Analysis Specialist to review and analyze complex medical instrumentation, documenting findings in the Quality Management System and supporting regulatory compliance. The role requires strong problem-solving skills, cross-functional communication, and mentoring capabilities.

You will handle instrument disposition, assist with RMA returns, and ensure accurate documentation while maintaining safety and quality standards in a fast-paced environment.

Qualifications

  • Experience performing failure analysis of defective instruments and accessories.
  • Ability to document findings clearly in the QMS.
  • Knowledge of regulatory requirements for reportable events and recalls.
  • Ability to read engineering drawings and understand schematics.
  • Independent problem solving and quick learning in a team setting.

Responsibilities

  • Perform failure analysis of defective instruments and accessories.
  • Disposition of Excess and System Trade in RMA I&A returns.
  • Instrument repacking and label printing work orders.
  • Document failure analysis findings in the QMS.
  • Support regulatory requirements for reportable events and recalls.
  • Communicate with failure analysis engineering and post‑market surveillance teams.
  • Verify assembly documentation accuracy and read drawings.

Skills

Failure analysis
Quality documentation
Regulatory awareness
Diagnostics software
Test equipment
Communication skills
Mentoring

Tools

Diagnostic software
Oscilloscopes
Multimeters
Calipers

Job description

Job Description

Primary Function of Position

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

Independently follows oral and/or written instructions in performance of a wide variety of inspections and testing of complex medical instrumentation and documents findings in Quality Management System. Responsible for timely processing and dispositioning of returned instruments and accessories.

Responsible for the timely processing and dispositioning of all RMA’s, with focus on Instruments and accessories.

Regularly use of diagnostic software for localizing equipment and system problems, specialized testing equipment, analyzers, digital oscilloscopes, digital multimeters, clocks, timers, calipers, voltmeters, power supplies, rulers, and other test equipment as required.

Essential Job Duties

  • Perform failure analysis of defective instruments and accessories by evaluating the mechanical, electrical, and physical characteristics of returned items.

  • Perform Disposition of Excess and System Trade in RMA I&A returns

  • Perform Instrument repacking process, including execution of label printing work orders

  • Documenting failure analysis findings in clear and concise way in QMS system

  • Assist Advance FA team on regulatory requirements in resolving “Reportable I/A” events and “Recalled” instruments.

  • Regular communication with failure analysis engineering group and post market surveillance

  • Able to perform Failure analysis of Core instrumentation and accessories.

  • Able to independently resolve minor to moderate problems.

  • Builds important internal/external relationships through advanced communication skills; knows how to influence and negotiate effectively through communications.

  • Mentors new team members as needed.

  • Ability to verify assembly documentation accuracy, read engineering drawings etc. Sets up and operates machines/equipment /fixtures needed to perform inspection and testing processes.

  • Understands diagrams, schematics, assembly drawings, fab drawings, mechanical component drawings.

  • Recommend/implements RMA process workflow improvements.

  • Disposes bio-hazardous material as required.

  • Performs “Purging tasks” for all the completed RMA’s if applicable.

  • Maintains knowledge of DOP’s, SOP’s and MPI’s pertaining to I/A RMA operations.

  • Works independently towards daily and throughput targets.

  • Follows all corporate, safety, SOP, DOP procedures and regulations.

  • Maintains a clean and orderly work area.

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