Quality Engineer – Surgical Guides

2 days ago

Sydney, New South Wales, Australia SPECIFICA PTY LTD Full time $100,000 - $140,000 per year


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

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