Quality Assurance Engineer

3 days ago


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

About RTI Surgical Inc

RTI Surgical Inc is a global leader in contract development and manufacturing organization (CDMO) in regenerative medicine.

We are seeking a highly skilled Quality Assurance Engineer to join our team

The ideal candidate will have a strong understanding of FDA QSR, MDSAP, Canadian and ISO 13485 Quality System requirements and be able to apply this knowledge in a fast-paced environment.

Earn a competitive salary of $95,000 - $110,000 per year

Key Responsibilities:

  • Technical Review: Conduct thorough technical review of all documents generated for inclusion in the Design History Files and process validation files.
  • Investigation and Resolution: Investigate customer complaints and participate in risk management activities to evaluate risks impacting the CBI quality system.
  • Collaboration: Collaborate with Clinical, Engineering, Regulatory and Operations personnel to perform complaint investigations and sponsor/coordinated CAPA activities.
  • Process Validation: Evaluate/audit new production processes for critical control points and recommend solutions.

Benefits:

  • Comprehensive health insurance
  • 401(k) retirement plan
  • Flexible work arrangements
  • Professional development opportunities

Required Skills and Qualifications:

  • Bachelor's degree in a relevant field
  • Minimum 5 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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