Sr. Quality Systems Manager

Location: On Site, West Lafayette, IN  

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

• Provides strategic leadership for the quality systems function including document control, audit program, post-market surveillance, Corrective and Preventative Action (CAPA) program, setting the goals for the department, and leading a high-performance team of quality professionals
• 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 
• Mentors quality systems personnel, and oversees training, performance management, resource allocation, and professional development for multiple functions    
• Establishes and maintains a culture of quality excellence throughout the team 
• Ensures compliance with relevant regulatory standards, including FDA, ISO, AATB and other applicable regulations
• Implements and maintains a robust quality management system to support product development, manufacturing, and distribution
• Manages the completion of regular audits to assess compliance with established quality processes and standards
• Analyzes data and metrics to identify areas for improvement and implement corrective and preventive actions
• Other duties as assigned

REQUIREMENTS

Education

Experience

• 9 years of experience in the medical device, pharmaceutical, HCT/P or biologics industry
• 6 years of experience in leadership

Skills 

• Excellent verbal and written communication
• Microsoft Office suite
• Quality Management System (QMS) software
• CAPA management
• Program management
• Process improvement methodologies

Travel 

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

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.