Quality Engineering Senior

Relocation bonus offered!

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

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.

Directly support quality systems and process improvement initiatives.

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

Minimum of 6 years of quality or engineering experience. Technical writing.

Microsoft Office Suite proficiency.

Experience with Quality Management System software.

Travel

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.) Onsite: Office environment with an assigned workstation.

Remote only: Home office environment with minimum distractions.

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