Quality Systems Supervisor

Location: On Site, Alachua, FL 

RTI Surgical is now Evergen!

This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.

Evergen 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, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.  

 Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM ;     

RESPONSIBILITIES

• Oversees and executes functions within critical Quality Systems programs to ensure compliance with applicable regulations, standards and company objectives, including, but not limited to, Document Control and Change Management. 
• Supports quality system compliance with the appropriate internal and external regulatory requirements and maintain awareness of the overall regulatory landscape.
• Collects, analyzes, and reports data elements to demonstrate conformity and maintains effectiveness of the quality management system with a high degree of accuracy.
• Supports company process improvement initiatives that impact quality systems and works collaboratively with cross-functional stakeholders to ensure compliance of processes and procedures within the quality management system.
• Support third-party audits, including Notified Body inspections, through audit planning, execution, closeout, and follow-up with a high level of customer service.
• Acts as a subject matter expert during internal and third-party audits for responsible processes.
• Reviews and approves quality system documentation for accuracy, consistency and compliance.
• Delivers training on responsible processes.
• Coordinates and leads daily team activities and performance management, hiring, scheduling, corrective actions, and other employee relations issues.
• Maintains records management system including secure storage, retrieval, retention, and destruction.
• Other duties as assigned

REQUIREMENTS

 Education

•  Associate’s Degree

Experience

• 3 years of experience in quality assurance, systems, regulatory affairs, or other relevant experience within a regulated industry such as tissue, medical device, or pharmaceutical.
• 2 years of leadership experience
• A different combination of education and experience may be considered. 

Skills 

• Excellent verbal and written communication
• Microsoft Office suite
• Quality Management System (QMS) software
• Problem Solving methodologies
• Data Analysis 
• Records Management

Travel 

• Minimal travel required, may occasionally travel for professional development or to support company initiatives.

SAFETY

Physical Requirement

• 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.)

Working Environment

• Onsite: Office environment with assigned workstation

More about Evergen:

Evergen 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. 

Evergen 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 Evergen, 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.