Quality Engineer – Surgical Guides

3 weeks ago

Sydney, New South Wales, Australia SPECIFICA PTY LTD Full time
Overview

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.

Responsibilities
  • Lead compliance activities and audit readiness for FDA 510(k) submissions and ISO 13485 audits.
  • Utilize direct surgical guide expertise (design, manufacturing, or quality) to support regulatory requirements and milestone delivery.
  • Collaborate with cross-functional teams to prepare documentation and processes for regulatory milestones.
Qualifications
  • 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.
  • 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.

Apply now by sending your CV to info@specifica.com.au.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Quality Assurance
Industries
  • Medical Equipment Manufacturing
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