Regenerative Medicine Quality Specialist

7 days ago


West Lafayette, Indiana, United States RTI Surgical Inc Full time

About Us

At RTI Surgical Inc, we're committed to delivering high-quality medical devices that improve patient outcomes.

We're seeking a talented Regenerative Medicine Quality Specialist to join our team

This role plays a critical part in ensuring the quality of our products, from design to delivery. If you're passionate about quality assurance and have a keen eye for detail, we'd love to hear from you

Earn a salary range of $90,000 - $105,000 per year

Responsibilities:

  • Design Reviews: Participate in design reviews and design input discussions to ensure compliance with regulatory requirements.
  • Risk Management: Participate in risk management activities to evaluate risks impacting the CBI quality system.
  • Document Control: Review and approve all documents generated in the development of the Design History File for protocol fulfillment, statistical validity, regulatory compliance, and auditability.

Requirements:

  • Bachelor's degree in a relevant field
  • Minimum 3 years of experience in quality assurance or related field
  • Strong understanding of FDA QSR, MDSAP, Canadian and ISO 13485 Quality System requirements

Location:

Alachua, FL, or West Lafayette, IN, USA



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