Quality Engineering Senior

Job Opportunity in Regenerative Medicine
Annual Bonus Opportunity up to $10,000.00
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; Evergen currently has full-time career opportunities available across multiple locations. Paid Time Off (PTO) 401(k) with up to a 6% company match Holiday pay Medical, dental, and vision insurance Short-term and long-term disability coverage Paid parental leave and much more!
Serves as a lead core team member of cross functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facility
Supervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiatives
Reviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streams
Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focus
Reviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives
Bachelor's degree in relevant technical discipline

6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
~*Technical writing
Microsoft Office Suite
Quality Management System software
Travel

• 75%) stationary position (standing or sitting) while utilizing digital displays
• 75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Onsite: Office environment with assigned workstation
Remote positions only: Home office environment with minimum distractions
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:

Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
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. 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.