Quality Engineer – Surgical Guides

4 days ago

Sydney, New South Wales, Australia Specifica Pty Ltd Full time

Overview
Join our surgical guide design company in Australia as we prepare for anFDA 510(k)submission andISO 13485audit.
We're looking for an experiencedQuality Engineerwith direct surgical guide expertise to lead compliance and audit readiness.
Responsibilities
Lead compliance activities and audit readiness forFDA 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 with510(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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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