QA Engineer- Medical Device

Analyze data (not just run SPC charts), from a wide variety of sources, examine processes for true systemic root cause and then take the improvement project from concept through validation with little or no direct supervision.

  •  Ideal candidates will have “classic quality” quality background and have experience in: OEM/CM operations, Soldering, Braising/Welding, Mechanical Assembly, PCBAs and Lean manufacturing methodologies.
  •  Must be able to write Assembly and Configuration process instructions, design and map efficient process flows. Develops, evaluates, revises, and applies technical quality assurance methods to inspect and test in-process raw materials, production equipment, and finished products.
  •  Ensures products and processes are compliant with company standards and applicable government regulations.
  •  Must Troubleshoot on mechanical issues, supplier assembly issues, BOM/order problems and process flows.
  •  Participates in NPI, BOM structure/review, ECO review.
  •  Work with key suppliers as needed on product issues and tactical activities in support of providing consistent high levels of quality for purchased products.
  •  Assist the strategic SQA team in the selection, evaluation and management of suppliers.
  •  Participate in the product line Failure Analysis & Improvement performing regular quality data reviews & analysis. Measurement of the cost of non-quality in the factory,
  •  Drive root cause corrective or preventive action in design, test or manufacturing changes as appropriate to the situation.
  •  Performs final acceptance testing of products.

 

Experience:

  •  A Bachelor’s Degree and 2+ years Quality Engineering experience in medical device and/or electronic assembly.
  •  ISO quality systems & internal auditing experience in Document control, Procedure writing, Employee training & certification, Product and process audits, Corrective and preventive action processes (5D/8D)

 

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