Senior Quality Assurance Engineer

2 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $120,000 - $180,000
Quality Assurance Specialist – Medical Device Engineering

Job Overview:

Our organization is seeking a seasoned Quality Assurance Specialist to spearhead compliance initiatives and audit readiness for FDA 510(k) submissions and ISO 13485 audits.

The ideal candidate will have extensive experience in medical device engineering, particularly in design, manufacturing, or quality assurance.

Key Responsibilities:
  • Develop and execute comprehensive compliance strategies to ensure regulatory milestones are met.
  • Collaborate with cross-functional teams to prepare documentation and processes for audit readiness.
Required Qualifications:
  • Hands-on experience in medical device engineering (design, manufacturing, or quality assurance).
  • Proven track record of successfully navigating 510(k) submissions.
  • Strong understanding of ISO 13485, FDA 21 CFR 820, ISO 14971, and TGA/MDSAP regulations.
  • Experience working with Class II / implantable devices.

About This Role:

This position offers an excellent opportunity for a motivated and experienced professional to join our team and contribute to the development and implementation of quality assurance initiatives.

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