
Surgical Guides Quality Assurance Specialist
7 days ago
We are seeking an experienced professional to lead quality assurance for our surgical guides.
Responsibilities- Lead quality assurance activities and compliance readiness for regulatory milestones.
- Utilize expertise in surgical guide design, manufacturing, or quality to support regulatory requirements and milestone delivery.
- Collaborate with cross-functional teams to prepare documentation and processes for regulatory milestones.
- Hands-on experience with surgical guides (design, manufacturing, or quality).
- Proven track record with regulatory submissions.
- Strong knowledge of relevant standards and regulations.
- Experience with Class II / implantable devices.
- SUCCESSFUL COMPLETION OF REGULATORY MILESTONES
- IMPROVED QUALITY ASSURANCE EFFICIENCIES
- ENHANCED COLLABORATION WITH CROSS-FUNCTIONAL TEAMS
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Surgical Guide Quality Assurance Specialist
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Quality Engineer – Surgical Guides
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Quality Engineer – Surgical Guides
1 week ago
Sydney, New South Wales, Australia SPECIFICA PTY LTD Full timeOverviewJoin 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.ResponsibilitiesLead compliance activities and audit readiness for FDA 510(k) submissions and ISO 13485...
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Quality Engineer – Surgical Guides
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Quality Expert
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