Quality Systems Lead: eQMS, CAPA & Audit Expert

ELITechGroup; Tucson (AZ); On-site; USD 75,000 - 110,000; Full time

Job summary

ELITechGroup is seeking a Quality Systems professional to support and improve the Quality Management System, focusing on NCP and IMT processes. You will help manage quality documentation, calibration, and CAPA activities while ensuring robust record control.

The ideal candidate holds a Life Science or Engineering degree with 3+ years in manufacturing quality and eQMS experience, and is comfortable working with audits and process improvements.

Qualifications

• Requires a Bachelor’s degree in Life Science or Engineering and 3+ years in quality within manufacturing; extensive eQMS experience preferred.
• Strong knowledge of ISO 13485 and FDA 21 CFR 820 quality systems; experience with NCR, CAPA and calibration programs desirable.
• Proficiency with documentation control, record keeping, and data analysis using PC tools.

Responsibilities

• Supports the Quality Management System and related processes, work instructions, and records.
• Leads Nonconforming Product (NCP) and IMT equipment processes with root cause analysis.
• Oversees calibration activities, both in-house and external, and maintains related records.
• Participates in CAPA, audits, and complaint handling; supports corrective/preventive actions.
• Maintains document and record control and supports process improvements.

Skills

Quality management

NCR handling

CAPA

Audits

Document control

eQMS experience

Education

Bachelor's in Life Science or Engineering

Tools

eQMS software

MS Excel

Job description

ELITechGroup is seeking a Quality Systems professional to support and improve the Quality Management System, focusing on NCP and IMT processes. You will help manage quality documentation, calibration, and CAPA activities while ensuring robust record control.

The ideal candidate holds a Life Science or Engineering degree with 3+ years in manufacturing quality and eQMS experience, and is comfortable working with audits and process improvements.