Senior Technical Reviewer

4 weeks ago


Lafayette, Louisiana, United States RTI Surgical® Full time
Job Summary:

This position plays a critical role in ensuring the quality and integrity of our Design History Files and process validation files. The successful candidate will be responsible for conducting thorough technical reviews, investigating customer complaints, and evaluating risks impacting our CBI quality system.

Key Responsibilities:

Participate in design reviews and design input discussions
Develop and review protocols for process validation and Design History File documentation
Conduct risk assessments and investigations of non-clinical complaints
Collaborate with Clinical, Engineering, Regulatory, and Operations personnel to perform complaint investigations
Evaluate and audit new production processes for critical control points and recommend solutions
Sponsor and coordinate CAPA activities
Participate in internal audits

Requirements:

Strong understanding of FDA QSR, MDSAP, Canadian, and ISO 13485 Quality System requirements
Excellent collaboration and communication skills
Ability to work independently and consult with supervisor as needed
Bachelor's degree in a related field and 2+ years of experience in quality assurance or a related field

Work Environment:

This position requires the ability to perform the essential functions of the job with or without reasonable accommodations. Limited exposure to hazardous chemicals used in the manufacture of the product is expected.

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