Quality Engineer

2 weeks ago


Grand Rapids, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • Supporting quality improvement projects through Corrective and Preventive Action (CAPA) process.
  • Facilitate document change control and training through integration of company procedures at the Grand Rapids site.
  • Develops, modifies, and executes validation protocols / reports (IQ, OQ, PQ, and/or TMV).
  • Implements production and process controls to ensure identification and traceability throughout the manufacturing process.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
  • May specialize in the areas of production control, product evaluation and reliability, inventory control and/or packaging as they apply to product or process quality.
  • Creating and performing validation protocols and reports (IQ, OQ, PQ, and/or TMV).
  • Creates engineering change orders through the company's document control process.
  • Implements quality improvement projects through Corrective and Preventive Action (CAPA) process.
  • Bachelor's degree in engineering, Science, or technical field with 4+ years of work experience in Engineering and/or Quality

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