Quality Director

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:

• Provide strategic direction and leadership for the QA and QC teams, ensuring compliance with regulatory requirements and industry standards including, but not limited to 21 CFR 820 and 211, ISO 13485, MDSAP, and ISO 14971.
• Analyze data and metrics to identify areas for improvement and implement corrective/preventive actions. Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve manufacturing processes.
• Work closely with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality standards are met throughout the product lifecycle.
• Ensure timely completion of quality-related projects and activities, supporting overall project timelines and goals.
• Maintain a state of audit readiness, ensuring all quality systems and processes are compliant with regulatory requirements and prepared for internal and external audits. Represent the QMS internally (Site Lead) and to external entities/partners.
• Provide thought leadership and guidance to all site teams, fostering a culture of quality and continuous improvement
• Oversee the development and maintenance of quality documentation, including SOPs, work instructions, and quality records
• Collaborate with Corporate Training department to develop and implement training programs to ensure all employees are knowledgeable about quality standards and procedures.
• Identify and mitigate quality risks, ensuring proactive measures are in place to address potential issues.

REQUIREMENTS

Education: 

Experience: 

• 10 years of experience in the medical device, pharmaceutical, HCT/P or biologics industry
• 7 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:

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: 

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.

#LI-Onsite