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Validation Specialist

2 months ago


Banana Shire, Australia Human4Human Recruitment Full time
{"title": "Validation Engineer", "description": "Job Summary

We are seeking a skilled and experienced Validation Engineer to join our team and contribute to the advancement of medical implant technologies.

Key Responsibilities
  • Interpreting and guiding on regulations, standards, and validation processes in manufacturing medical devices
  • Developing validation procedures with the Corporate Validation Team
  • Becoming a Subject Matter Expert (SME) in multiple validation specialties
  • Advising on process improvement and validation strategies
  • Crafting validation plans, protocols, and reports (IQ, OQ, PQ)
  • Coordinating with stakeholders for unified validation procedures
  • Addressing out-of-spec results and proposing fixes
  • Applying validation principles across processes, equipment, and methods
  • Supporting validated state through work instructions and risk analysis
  • Delivering technical presentations to stakeholders
Requirements
  • Bachelor's or Master's degree in Mechanical Engineering or related field
  • At least 3 years of experience in validation engineering
  • Fluency in English
  • Experience in the medical or healthcare industry (must have)
  • Strong grasp of regulations, standards, and validation
  • Proven skill in creating validation plans, protocols, and reports
  • Excellent communication and analytical skills
  • ISO 13485 familiarity a plus
What We Offer
  • Competitive salary correlated with skills and mindset
  • Participating in the newest technology solutions, classified products, and services
  • A company culture based on autonomy, high-trust, and accountability
  • 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 growth opportunities awarded with Great Place to Work 2023
Recruitment Process
  • Send your CV via H4 H form or email
  • 10-20 minutes phone call with H4 H IT Consultant to enrich your application with missing details
  • 15-30 minutes video call with our Partner's Tech Leader to evaluate your skills
  • 15-30 minutes video call with end Client representatives to ensure good understanding of the role and enable you to ask any questions regarding your new role
  • Short video-call or phone call with our Partner's HR Business Partner to check in-depth the alignment between you and the values and culture of the Company
  • Financial negotiations are welcomed
About Our Recruitment Process

Our recruitment process is tailored to do our best to avoid that you or we realize that we're not a perfect fit in two or six months.

It might seem long, but every step serves a purpose and will allow us to get to know you better as much as it'll help you understand more where you'll be stepping in.

We also want you to have time to ask all your questions regarding your job description, the long-term vision of your team and the company, our values, with the relevant interlocutor in front of you.

The steps mentioned above can be rearranged depending on yours and the interviewer's availability.

How to Nail Your Application
  • Tailor your CV & application to our specific job description and company
  • Attention to detail is important as an employee as it is as an applicant
  • Complete the different steps of the application process in a timely manner, to ensure you don't miss out on this opportunity
  • Help us synchronize your availability with our Managers' calendars to fulfill the video calls
  • Prepare your interviews and the questions you will ask at each step, depending on who's conducting it
  • Any copy-pasted or non-personalized application will not be considered
  • Non-UE citizens will not be considered due to project requirements
"}