Quality Inspector 2
Job Title: Quality Inspector 2
Department: Quality Control
Effective Date: 03/17/2023
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).
RTI Surgical is a 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 judgment and holding 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 Greenville, N.C. and Germany.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
The Quality Inspector 2 Position at RTI requires proficiency in at least two relevant inspection competencies. Inspector must be proficient in tasks and perform tasks for at least a year. Quality Inspector 2 will continue to analyze and monitor product quality in accordance with established procedures. Employee will also examine in-process and/or finished products for compliance with set quality criteria.
- Review, test, and inspect medical device/tissue/equipment to ensure compliance with quality standards.
- Ensure all non-compliance issues associated with inspections are accurately reported.
- Perform all routine AQL inspections and conduct 100% inspections on AQL inspection failures.
- Evaluate and document finished product for acceptance.
- Performance activities to complete Certificate of Conformance, where applicable.
- Performance activities to complete TMI inspections, where applicable.
- Perform final product testing, where applicable, for product release.
- Sample, analyze, and monitor product quality in accordance with established procedures.
- Examine in-process and/or finished products for compliance with set quality criteria.
- Perform adequate cycle counts.
- Conduct and document process reviews using standard forms/documentation.
- Communicate issues to Quality support.
- Conducts routine tasks as directed.
- Other duties as assigned
- Ability to solve problems with problem solving techniques
- Ability to work in a team environment, exhibits a positive work attitude and respects fellow employees
- Participates in team meetings
- Understands and takes responsibility for customers upstream and downstream of his/her activities
- Identifies and facilitates continuous improvement efforts in the areas of: quality, safety,, compliance, and waste reduction.
- Participate in continuous improvement activities in team meetings and other formal and informal settings.
- Performs training for other employees that result in positive or improved performance by the trainee.
- Acts as an example and leader for other employees in the workgroup to grow and develop in their technical and team building skills
- Follows assigned priorities from manager
- Ability to work with minimal supervision
- Understands and complies with safety requirements
- Performs duties while meeting all applicable internal, federal and state quality requirements and regulations
- Participates in periodic performance reviews on a timely basis
- Displays proficiency (preferably mastery) in multiple RTI inspection processes
- Ability to take initiative and work independently
- Must be observant and very good at paying attention to detail
- Basic computer software skills, including but not limited to: MS Office, Excel, and Access
- Knowledge (or ability to learn) relevant T-track functions
- Ability to utilize measurement and inspection tools (e.g. calipers, gages, manometer, microscope)
- Ability to record and review information accurately
- Flexibility based on plant production schedules
- Effective written and oral communication skills
- Capable of communicating efficiently with management and help to analyze and correct the production problems
- Ability to follow documented procedures and standards
- Willingness to handle and process human and xenograft tissue
- HS diploma or equivalent required
- Three years’ experience or equivalent education preferred
Light work: Physically handle objects up to 20 lbs. occasionally. This position may require the use of personal protective equipment during various tasks/activities including but not limited to, gloves, masks and safety glasses.
Office Setting - Open layout with assigned work station or office