Quality Technician

Job Title: Quality Technician, Supplier Quality
Department: QA - Tissue
Effective Date: 7/28/2022
Location: Alachua, FL

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).

SUMMARY:
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.

RESPONSIBILITIES:

• Provides quality support for Quality Assurance functions with a focus in Supplier Quality and leads activities as assigned.
• Performs investigations for direct and indirect supplier related 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 controlled process inputs (MRB).
• Authors and executes new supplier qualification activities.
• Performs process versus procedure audits and documents the results appropriately.
• Assists in maintaining relevant WI’s, SOP’s and other documentation.
• Assists in documentation of quality inspections on controlled suppliers.
• Initiates and/or performs reviews of non-conformance or other evaluation records within the Supplier Quality program.
• Assist and / or leads efforts to maintain Approved Supplier List monitoring activities.
• Provides support as necessary for investigations related to Sterility Assurance programs or other Quality Engineering functions as assigned.

CORE COMPETENCIES:

• Ability to take initiative and work independently
• Basic computer software skills, including but not limited to: MS Office and Excel
• Knowledge of (or ability to learn) relevant software applications (SAP, SmartSheet)
• Ability to record and review information accurately
• Effective written and oral communication skills
• Willingness to handle and process human and animal tissue

EDUCATION/EXPERIENCE REQUIRED:

• 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).

Physical Requirements:
Light work: Physically handle objects up to 20 lbs. occasionally.

Work Environment:
Office Setting - Open layout with assigned work station or office