Koch
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Engineer, Quality

Description


What You Will Do In Your Role

  1. Create and maintain PPAP packages—APQP, PFMA, control plan, SPC, MSA, ect., and submit to customer for approval.
  2. Create all Quality plan/Inspection instruction for products, and perform the training to the responsible person.
  3. Create the SPC method for process control, and perform the training to the responsible person.
  4. Create all the record templates for the product inspection activities.
  5. Conduct the validation protocol creation and execution.
  6. Customer compliant handing, lead root cause analysis and implement improve action and prevent action, finish 8D or CAPA report and review with customer.
  7. Support plant continuous improvement/scrap reduction project.
  8. Other duties as assigned by supervisor.

The Experience You Will Bring

Requirements:

  1. 3-5 years working experience in medical device or pharmaceutical manufacturer.
  2. Experienced in validation process .
  3. Induvidually handle new project quality plan set up and validation protocol creation.
  4. Knowledge in ISO9001/ISO 13485/GMP.
  5. Knowledge of FMEA/SPC/QC 7 tools/8D.
  6. Good communication skills.
  7.  Strong problem solving skills. 
  8. Good analytic senses.
  9. Flunt English both in written and oral.

What Will Put You Ahead

  1. Be familiar with measurement equipments.
  2. Be familiar with the high-automation assembly process.
  3. Experience in Software validation.

#LI-AZ1

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