Quality Assurance Leader

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:

• Develops and implements effective quality practices and manages support related to Design Control, Risk Management, Quality Planning, and other Quality Engineering support for new product development (NPD) of HCT/Ps and Medical Devices
• Supports the development and implementation of written quality policies and procedures to assure compliance with all applicable federal, state, and local regulations and industry standards
• Participates in third-party audits and inspections conducted by state and federal regulatory agencies and accreditation bodies
• Mentors assigned quality assurance personnel and oversees their training, performance management, resource allocation, and professional development
• Manages process for evaluating non-conformances and deviations in Operations including support for Corrective Action / Preventative Action and Non-conformance workflows
• Develops quality objectives and metrics to continuously monitor processes and provide performance summaries to executive management
• Identifies, evaluates, and implements process improvements
• Collaborates with quality leaders to develop and set priorities to support quality and business objectives
• Other duties as assigned

REQUIREMENTS

Education:

Bachelor's degree in relevant discipline

Experience:

Manager: 5+ years of quality assurance experience in the medical device, pharma, HCT/P, or biologics industry; 3+ years of leadership experience

Sr. Manager: 9+ years of quality assurance experience in the medical device, pharma, HCT/P, or biologics industry; 6+ years of leadership experience

Skills:

• Excellent verbal and written communication
• Microsoft Office Suite, intermediate Excel
• Statistical techniques
• Problem-solving methodologies
• Technical writing
• Quality Management System (QMS) software

Travel: