Quality Assurance Engineer

LENSAR•Orlando, FL
•Hybrid

About The Position

The Quality Assurance Engineer works with Manufacturing, R&D, Purchasing and Supplier Quality Engineers to execute all Manufacturing QA activities for LENSAR. This person shall review Device History Records for accuracy and completion, monitor and trend manufacturing nonconformance data, and recommend corrective actions. The Quality Assurance Engineer will work with the Supplier Quality Engineer and Receiving Inspection to correct Supplier caused nonconformities.

Requirements

  • Bachelor’s degree in technical discipline, preferably mechanical.
  • Minimum 1+ years’ experience in a manufacturing environment within a regulated environment.
  • Strong communication and interpersonal skills.
  • Strong problem identification and problem-solving abilities.
  • Strong MS Office skills.
  • Ability to read and interpret documents such as Engineering Drawings/ Specifications, Operating Procedures and Work Instructions.
  • The ability to travel throughout the U.S. is required at less than 5%.

Nice To Haves

  • Experience working in a regulated industry, ie. ISO9001, ISO13485.
  • Experience with Solid Works.

Responsibilities

  • Provide Quality Engineering support to manufacturing including validation activities, data analysis, report and protocol writing, problem solving and continual improvement.
  • Perform device History Record Reviews for assigned product lines.
  • Review nonconforming parts and sub-assemblies for proper initial disposition and root cause follow-up.
  • Work with Receiving Inspection and Supplier Quality Engineering to develop inspection standards for parts and subassemblies.
  • Assist production in prevention of defect occurrence and recommend process changes.
  • Participate in the Engineering Change Process by reviewing and evaluating recommended changes and determining impact of changes on current inspection activities.
  • Perform mechanical and other inspections in support or receiving inspection as required.

Benefits

  • Annual bonus opportunity
  • Company matched 401(k) plan with eligibility day one and immediate vesting
  • Employee Stock Purchase Plan (ESPP) and other company equity programs
  • Employer-sponsored comprehensive health plans- medical/dental/vision
  • Employer-paid disability insurance
  • Voluntary life insurance
  • Generous company holiday schedule
  • Paid time off program
  • Company-wide paid shutdown during the holidays
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