Sr. Quality Engineer

Relocation bonus offered!

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine.

West Lafayette, IN

• Develop a strong network of cross‑functional colleagues, understand business goals, prioritize projects, and communicate and facilitate effectively to support the Quality Assurance function.
• Support product development processes, including review and approval of design project deliverables, collaboration with core teams, and review and approval of risk management deliverables.
• Lead investigations for product nonconformances and process noncompliance issues, document findings in the Corrective Action/Preventive Action (CAPA) system, and select appropriate methods and techniques for solutions.
• Participate in risk assessment, review, and disposition of nonconforming products, including complaints.
• Perform CAPA activities, including root cause analysis, investigations, product and process disposition, risk management, and effectiveness checks.
• Support supplier qualification activities, including completing and maintaining supplier qualifications, collaborating with suppliers on corrective actions, performing supplier audits, and assessing supplier risk.
• Support validation activities, including reviewing and approving validation protocols and reports.
• Interpret and apply appropriate sampling plans and statistical techniques.
• Ensure proper change control, including initiating change plans, updating Work Instructions and Standard Operating Procedures, and obtaining documentation approvals.
• Directly support quality systems and process improvement initiatives.
• Support and perform internal and external audits.
• Perform other assignments as directed.

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

Minimum of 6 years of quality or engineering experience. Education may be substituted if the required experience is not met.

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

N/A

• 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.
• Perform fine manipulation with hands and fingers (typing, opening, writing, clicking, paper sorting, etc.) more than 75% of the time.

• Onsite:
  Office environment with an assigned workstation.
• Remote only:
  Home office environment with minimum distractions.