Quality Engineering Senior

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Quality Engineer
Full-Time Alachua, FL, US

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., 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

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.)

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.

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.