Quality Systems Specialist – GMP & ISO 13485

Erbe Medical, LLC; Tempe (AZ); On-site; USD 70,000 - 100,000; Full time

Job summary

Erbe Medical, LLC in Tempe, AZ is seeking a Quality Systems professional to support the QMS, CAPA, Design Control, Change Control and Records Control, ensuring regulatory compliance with FDA 21 CFR 820 and ISO 13485. You will assist with document control, training records, audits, and ongoing system improvements while maintaining cGMP and GDP standards, and coordinating with cross-functional teams.

This role requires 2–5 years in Quality Systems and a high school diploma; bilingual Spanish

Qualifications

• 2–5 years of experience in Quality Systems.
• Experience in medical device or regulated industry.
• QMS experience required.
• Bilingual Spanish preferred.

Responsibilities

• Assist development, implementation, and monitoring of QMS including CAPA.
• Support Design Control, Change Control, Document Control and DHR.
• Provide training on document control processes.
• Participate in internal and external audits.
• Ensure compliance with FDA/ISO requirements.
• Maintain training records and CCP/QRR processes.

Skills

QMS experience

Document control

CAPA

Audits

Regulatory compliance

Bilingual Spanish

Education

High School Diploma

Tools

MS Office

Job description

Erbe Medical, LLC in Tempe, AZ is seeking a Quality Systems professional to support the QMS, CAPA, Design Control, Change Control and Records Control, ensuring regulatory compliance with FDA 21 CFR 820 and ISO 13485. You will assist with document control, training records, audits, and ongoing system improvements while maintaining cGMP and GDP standards, and coordinating with cross-functional teams.

This role requires 2–5 years in Quality Systems and a high school diploma; bilingual Spanish