While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
RTI Surgical is global, industry-leading private label OEM with expertise in allograft, xenograft and synthetic-based implants. RTI began operations in 1998 when it spun off from the University of Florida Tissue Bank in 1998 with the goal of expanding the gift of tissue donation by pioneering tissue-based innovations that promote natural healing. Today, through integrated partnerships with customers, RTI develops and delivers restorative solutions to physicians and their patients.
As a Private Label Original Equipment Manufacturer (PLOEM) partner, RTI provides comprehensive turn-key services for development and product life cycle management in support of patients and leading medical technology companies. RTI’s implants are used in multiple surgical applications including dental, spine, sports medicine, plastic and reconstructive surgery, urology/urogynecology and trauma.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on four key values:
We are accountable to each other by trusting each other’s judgement and hold each other responsible for results.
We find joy by striving to create a working environment that people enjoy.
We fully engage by focusing our hearts and minds on our customers, patients, and each other.
We adapt to change by working collaboratively to be flexible to the changing needs of our business.
RTI’s headquarters is located near Gainesville, Fla. in North Central Florida’s growing life sciences region, and has additional state-of-the-art facilities in the Greenville, N.C. and Germany.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and have supported the transformation of the company to its next level of potential.
Provides quality support for Quality Engineering functions with a focus in Sterility Assurance (Environmental Monitoring, Environmental Control, and Product Sterility), and leads activities as assigned.
Performs investigations for product, or product related testing nonconformance/process noncompliance issues and documents exceptions appropriately in the CAPA System.
Performs CAPA investigations as assigned.
Participates and / or leads review and disposition of non-conforming product (PQRB / returns / complaints).
Authors and executes validation protocols and documents the results in a validation report.
Performs process or product audits and documents the results appropriately.
Assists in maintaining relevant WI’s, SOP’s and other documentation.
Performs quality inspections of facilities, data entry, and data corrections.
Initiates and/or performs reviews of non-conformance or other evaluation records within the Sterility Assurance programs.
Assists in performing, documenting and training personnel to environmental monitoring, environmental control and facility/equipment cleaning activities.
May assist in performing, documenting and training personnel to comply with aseptic techniques and practices.
Provides support as necessary for investigations related to Sterility Assurance programs or other Quality Engineering functions as assigned.
Ability to take initiative and work independently
Basic computer software skills, including but not limited to: MS Office, Excel, and Access
Knowledge of (or ability to learn) relevant software applications (T-track, LIMS)
Ability to utilize general laboratory equipment or measurement and inspection tools (e.g. calipers, gages, microscope)
Ability to record and review information accurately
Effective written and oral communication skills
Willingness to handle and process human and animal tissue
High School diploma and at least one year experience in tissue bank, medical device or Quality Control environment.
Preferred Qualifications (one or more may apply):
AA required or High School diploma plus at least three years’ experience in tissue bank, medical device or Quality Control environment.
Bachelor’s degree (nonspecific discipline with coursework in Biology, Microbiology, or closely related discipline).
Light work: Physically handle objects up to 20 lbs. occasionally.
Office Setting - Open layout with assigned work station or office