Quality Assurance Specialist
3 days ago
Job Title: Quality Assurance Specialist - Surgical Instrumentation
About the Role:
We are seeking a highly skilled Quality Assurance Specialist to lead our surgical instrumentation compliance and audit readiness efforts. This is a critical role in achieving major regulatory milestones, requiring strong expertise in quality assurance, regulatory affairs, and surgical instrumentation.
Key Responsibilities:
- Lead quality assurance activities and audit readiness for FDA 510(k) submissions and ISO 13485 audits.
- Collaborate with cross-functional teams to prepare documentation and processes for regulatory milestones.
- Utilize direct surgical guide expertise (design, manufacturing, or quality) to support regulatory requirements and milestone delivery.
Requirements:
- Hands-on experience with surgical instruments (design, manufacturing, or quality).
- Proven track record with 510(k) submissions and ISO 13485 audits.
- Strong knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, and TGA/MDSAP regulations.
- Experience with Class II / implantable devices.
Why Us?
This is a unique opportunity to work at the cutting edge of surgical device innovation, driving regulatory excellence and advancing patient care.
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