At a Glance
- Tasks: Assist in validating computer systems for medical device manufacturing and draft essential documentation.
- Company: Join PolyNovo Limited, a leader in innovative medical devices based in Melbourne.
- Benefits: Gain valuable experience in a growing industry with competitive pay and career advancement.
- Other info: Collaborative team environment with opportunities to work on impactful projects.
- Why this job: Make a difference in healthcare by ensuring quality and compliance in medical technology.
- Qualifications: Experience in computer systems validation and knowledge of ISO 13485 and FDA standards.
The predicted salary is between 72000 - 88000 $ per year.
PolyNovo Limited in Melbourne is seeking a Computer Systems Validation Engineer to join the Manufacturing team. Reporting to the Validation Engineering Manager, you will assist in implementing and validating computer systems (MES, eQMS, EMS) in accordance with medical device manufacturing standards.
You will draft validation plans and reports, contribute to SOPs, and ensure documentation meets ISO 13485 and FDA requirements, while coordinating with cross-functional teams and maintaining quality.
CSV Engineer – Medical Devices, MES/eQMS Specialist in Melbourne employer: PolyNovo Limited
PolyNovo is an exceptional employer located in Melbourne, offering a dynamic and inclusive work culture that prioritises employee growth and development. With a commitment to innovation in medical technology, employees benefit from unique career advancement opportunities, access to extensive online learning resources, and a supportive environment that values diversity and collaboration. The company's focus on quality and patient safety ensures that every team member plays a vital role in making a meaningful impact on lives globally.
