Sr. Quality Engineer

Location: West Lafayette, IN Salary: $100,000 to $120,000 Annual Bonus eligibility: $10,000 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; Eden Prairie and Glencoe, MN; Neunkirchen, Germany; Glasgow, UK; and Marton, New Zealand. We are proud to be Great Place to Work® Certified in 2026 , reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations. Our comprehensive benefits package includes: 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! Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://www.linkedin.com/company/evergenbio RESPONSIBILITIES 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 Supports validation activities inclusive of reviewing and approving validation protocols and reports Interprets and applies appropriate sampling plans and statistical techniques Ensures proper change control including initiating change plans, updating Work Instructions and Standard Operating Procedures, and documentation approvals Directly supports the quality systems and process improvement initiatives Supports and performs internal and external audits Other duties as assigned REQUIREMENTS Education Bachelor’s degree in Engineering or relevant technical discipline Experience Minimum of 6 years of…