Validation Engineer

7 days ago

Banana, Australia Human4Human Recruitment Full time
About the Role

We are seeking a skilled and experienced Validation Engineer to join our team at Human4Human Recruitment. As a Validation Engineer, you will play a crucial role in ensuring the quality and safety of medical devices.

Key Responsibilities
  • Interpret and apply regulations, standards, and validation processes in the manufacturing of medical devices.
  • Develop validation procedures with the Corporate Validation Team.
  • Become a Subject Matter Expert (SME) in multiple validation specialties.
  • Advise on process improvement and validation strategies.
  • Craft validation plans, protocols, and reports (IQ, OQ, PQ).
  • Coordinate with stakeholders for unified validation procedures.
  • Address out-of-spec results and propose fixes.
  • Apply validation principles across processes, equipment, and methods.
  • Support validated state through work instructions and risk analysis.
  • Deliver technical presentations to stakeholders.
Requirements
  • Bachelor's or Master's degree in Mechanical Engineering or a related field.
  • At least 3 years of experience in validation engineering.
  • Fluency in English.
  • Experience in the medical or healthcare industry (required).
  • Strong grasp of regulations, standards, and validation.
  • Proven skill in creating/validation plans, protocols, reports.
  • Excellent communication and analytical skills.
  • ISO 13485 familiarity a plus.
What We Offer
  • A competitive salary package.
  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.
  • Full-time permanent contract of employment.
  • PPK – employee pension program.
  • Lux Med – private medical care for employees and family members.
  • Exciting and challenging projects.
  • Collaborative and dynamic environment.
  • Being part of an ambitious company with a lot of growth opportunities.
Recruitment Process
  • A 10-20 minutes phone call with our IT Consultant to enrich your application.
  • A 15-30 minutes video call with our Tech Leader to evaluate your skills.
  • A 15-30 minutes video call with our end Client representatives to ensure good understanding of the role.
  • A short video-call or phone call with our HR Business Partner to check in depth the alignment between you and our company values and culture.

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