Quality Engineering Senior

Annual Bonus eligibility: $Relocation bonus offered!
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.
Holiday pay

• Medical, dental, and vision insurance
• Short-term and long-term disability coverage
• Develops strong network of cross-functional colleagues, a deep understanding of business goals, project prioritization, and strong communication and facilitation skills to support the Quality Assurance function.

Supports product development processes inclusive of review and approval of design project deliverables, collaboration with core teams, and review and approval of risk management deliverables
Leads investigations for product nonconformances, process noncompliance issues, documents these appropriately in the Corrective Action / Preventive Action (CAPA) system, and demonstrates good judgment in selecting methods and techniques for obtaining solutions
Participates in risk assessment, review, and disposition of nonconforming products including complaints
Performs CAPA activities inclusive of root cause analysis, investigations, product and process disposition, risk management, and effectiveness check
Supports supplier qualification activities inclusive of completing and maintaining supplier qualifications, working with suppliers to address corrective actions, performing supplier audits, and assessing supplier risk
Directly supports the quality systems and process improvement initiatives
Bachelor’s degree in Engineering or relevant technical discipline

Minimum of 6 years of quality or engineering experience required. 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.

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