Quality Assurance Engineer

3 days ago


Sandy Springs GA USA, United States Stryker Full time
About the Role

Stryker is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality of our products and processes.

Key Responsibilities
  • Support quality issues impacting daily operations and advocate for initiatives to enhance quality performance.
  • Own identified internal and supplier non-conformances and manage timely closure.
  • Own or support identified internal CAPAs and manage to timely root cause investigation, implementation, and closure.
  • Disposition non-conforming product within MRB and issue NCs as appropriate.
  • Perform critical assessment of internal and supplier proposed change management activities.
  • Perform PPAP activities for supplier changes.
  • Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
  • Support and drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
  • Collaborate with stakeholders to identify and execute opportunities for supplier part certification.
  • Develop understanding of risk management practices and concepts and apply knowledge to manufacturing operations.
  • Support the creation and maintenance of inspection methods and sampling.
  • Support the development and review of process and equipment validation/qualification and MSA of internal processes.
  • Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
Requirements
  • Bachelor's degree in science, engineering, or related discipline.
  • 4+ years' experience in quality, engineering, manufacturing, and/or operations within a highly regulated industry.
  • Experience with ISO14971 and ICHQ9 risk management standards and guidance.
  • Experience in working in a compliance risk situation.
  • Strong quality background with CQE and/or Six Sigma Green or Blackbelt preferred.
  • Expertise in Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics, DMAIC, DFSS).
  • Strong interpersonal skills, written communication, oral communication, and negotiations skills.


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