Sr. Quality Engineer

Base Pay Range

$/yr - $/yr

West Lafayette, IN

Evergen (formerly RTI Surgical) is a leading CDMO in regenerative medicine headquartered in Alachua, FL with manufacturing facilities in West Lafayette, IN, Eden Prairie, MN, Glencoe, MN, Neunkirchen, DE, Glasgow, UK, and Marton, NZ. We offer a unique portfolio of allograft and xenograft biomaterials at scale.

• Develop strong network of cross‑functional colleagues, understand business goals, prioritize projects, and communicate effectively to support the Quality Assurance function.
• Support product development processes, including review and approval of design project deliverables and risk‑management deliverables.
• Lead investigations for product nonconformances and process noncompliance issues, document findings in the CAPA system, and select appropriate solution methods.
• Participate in risk assessment, review, and disposition of nonconforming products including complaints.
• Perform CAPA activities: root‑cause analysis, investigations, product and process disposition, risk management, and effectiveness checks.
• Support supplier qualification activities, including completing and maintaining qualifications, working with suppliers on corrective actions, performing audits, and assessing supplier risk.
• Support validation activities by reviewing and approving validation protocols and reports.
• Interpret and apply appropriate sampling plans and statistical techniques.
• Ensure proper change control: initiate change plans, update work instructions and SOPs, and obtain documentation approvals.
• Directly support quality systems and process‑improvement initiatives.
• Support and perform internal and external audits.
• Perform other duties as assigned.

• Bachelor’s degree in Engineering or a relevant technical discipline.

• Minimum six years of quality or engineering experience. Experience may substitute for education requirements.

• Excellent verbal and written communication.
• Technical writing.
• Problem‑solving methodologies.
• Proficiency with Microsoft Office Suite.
• Experience with Quality Management System software.

• N/A

Not specified.

• Move or lift objects up to 25 pounds.
• Spend more than 75% of time in a stationary position (standing or sitting) while using digital displays.
• Frequent fine manipulation with hands and fingers (typing, writing, clicking, sorting paper, etc.) more than 75% of time.

• On‑site:
  Office environment with assigned workstation.
• Remote positions only:
  Home office environment with minimum distractions.

Evergen provides customers across diverse market segments with leading‑edge expertise, scalability, and flexibility across end‑to‑end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Our core values—Accountable, Agile, Growth Mindset, Customer‑Centric, Inclusive—guide our commitment to quality, integrity, and patient safety.

Mid‑Senior level

Full‑time

Quality Assurance

Medical Equipment Manufacturing