Quality Expert

12 hours ago

Sydney, New South Wales, Australia beBeeSurgical Full time $100,000 - $140,000
Job Overview

Our surgical guide design company in Australia is preparing for an FDA 510(k) submission and ISO 13485 audit. We're looking for a Quality Engineer to lead compliance and audit readiness.

Key Responsibilities
  • Lead compliance activities and audit readiness for FDA 510(k) submissions and ISO 13485 audits.
  • Utilize expertise in surgical guides (design, manufacturing, or quality) to support regulatory requirements and milestone delivery.
  • Collaborate with cross-functional teams to prepare documentation and processes for regulatory milestones.
Required Skills and 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.
Benefits and Opportunities
  • Critical role in achieving major regulatory milestones.
  • Work at the cutting edge of surgical device innovation.

Apply now by sending your CV.

Seniority Level and Job Type
  • Mid-Senior level.
  • Full-time employment.
Job Function and Industry
  • Quality Assurance.
  • Medical Equipment Manufacturing.

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