Senior Validation Engineer

3 days ago

Banana Shire, Australia Human4Human Recruitment Full time
About the Role

We are seeking a highly skilled Senior Validation Engineer to join our team at Human4Human Recruitment. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and innovation in our products.

Key Responsibilities
  • Collaborate with cross-functional teams to drive quality and validation-related activities.
  • Evaluate the root cause of defects and identify trends in machining processes and product quality.
  • Provide technical expertise for projects, utilizing tools such as FMEA, risk mitigation, plant validations, DOE, and other experiments.
  • Apply a working knowledge of validations, IQ, OQ, PQ, SIMS, and DOE's to contribute to robust quality assurance processes.
  • Review vendor documents, identify gaps, and collaborate to close them.
  • Approve and assist in the launch of products, coordinating with vendors for PPAP documentation.
Requirements
  • Proven track record and hands-on experience in validations, IQ, OQ, PQ, SIMS, and DOE's.
  • Fluency in English.
  • Strong understanding and knowledge of machining processes, including defect remediation activities.
  • Good understanding and experience in Geometric Dimensioning and Tolerancing (GD&T) and complex drawing interpretation.
  • Hands-on experience in creating PFMEA, Process Control Plans, and coordinating with vendors for PPAP documentation.
  • Proven track record of supporting and driving continuous improvement activities in a production environment.
  • Effective coordination and communication skills to work with internal and external teams, ensuring successful project outcomes.
What We Offer
  • A highly competitive salary package.
  • Opportunities to work on exciting and challenging projects in the healthcare industry.
  • A collaborative and dynamic work environment in a global company.
  • Participation in the development of cutting-edge medical devices and solutions.
  • A chance to make a meaningful impact and contribute to the company's growth and success.

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