Onsite in 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 (RTI) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. RTI is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, Indiana and Neunkirchen, Germany.

RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:

• Accountable: We own our actions and decisions.
• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. 
• Growth Mindset: We embrace challenges as opportunities for continuous learning.
• Customer-Centric: We prioritize customers at every touch point. 
• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. 

At RTI Surgical, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

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.

RESPONSIBILITIES:

• Provides support for Quality Engineering functions such as manufacturing, sterility assurance, or supplier quality
• Supports investigations for product or supplier nonconformance and process noncompliance issues and documents exceptions appropriately in the Corrective Action / Preventative Action (CAPA) System 
• Supports CAPA investigations using problem-solving methodologies and a high attention to detail
• Participates in the review and disposition of non-conforming product or controlled process inputs including the Product Quality Review Board (PQRB), returns, and complaints 
• Supports the review of validation documentation or new supplier qualification activities quickly and accurately in collaboration with engineers
• Performs audits of products and processes and documents the results appropriately
• Assists in the Change Management function including maintaining relevant work instructions, Standard Operations Procedures (SOPs), and other quality documentation
• Performs product acceptance testing, quality inspections, data entry, and data corrections quickly and efficiently
• May provide support for environmental monitoring investigations, documentation of quality inspections on controlled suppliers, or support the Approved Supplier List monitoring activities
• Identifies and supports process improvement initiatives and implementation

REQUIREMENTS

Education: 

High School diploma or equivalent 

Experience: 

0-3 years of experience in quality assurance, quality control, or manufacturing 

Additional education may substitute for the experience requirement

Skills:

• Strong verbal and written communication 
• Microsoft Office Suite, basic Excel 
• Technical Writing 

SAFETY:

Physical Requirements: 

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Work Environment: 

• Onsite: Office environment with assigned workstation