Join our surgical guide design company in Australia
as we prepare for an
FDA 510(k) submission
and
ISO 13485 audit.
We're looking for an experienced Quality Engineer
with
direct surgical guide expertise
to lead compliance and audit readiness.
Must have:
* Hands-on experience with
surgical guides
(design, manufacturing, or quality)
* Proven track record with
510(k) submissions
* Strong knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, TGA/MDSAP
Highly preferred:
* Ex-Notified Body auditor
background
* Experience with Class II / implantable devices
Why join us?
* Critical role in achieving major regulatory milestones
* Work at the cutting edge of surgical device innovation
* Flexible/hybrid work arrangements
Apply now by sending your CV to