Junior QA/QC Engineer - Medical Devices

Hanger; Phoenix (AZ); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Competitive Compensation Packages

8 Paid National Holidays & 4 Floating

PTO including Vacation and Sick time

Medical, Dental, and Vision Benefits

401k Retirement Plan

Relocation Assistance

Job summary

Hanger, Inc. is seeking a QA Engineer I to support quality assurance and product development aligned with medical device regulations (21 CFR 820, ISO 13485). Under supervision, you will assist with incoming inspections, document control, CAPA investigations, and maintaining quality records.

You will collaborate with Product Development to complete design controls and participate in validation activities while supporting calibration and equipment maintenance programs.

Qualifications

• Experience with medical device quality systems is a plus.
• Familiarity with 21 CFR 820, 21 CFR Part 11, and ISO 13485 preferred.
• Experience with CAPA processes within a structured quality system is beneficial.

Responsibilities

• Support QA/QC activities following 21 CFR 820, ISO standards, and CE mark guidelines.
• Perform basic incoming inspections and final product checks using predefined criteria.
• Assist with complaint intake, document control, and maintaining quality records.
• Help track device history records, QA logs, test reports, and equipment records.
• Participate in IQ/OQ/PQ validation activities and calibration/maintenance scheduling.

Skills

QA fundamentals

Regulatory understanding

Documentation

Education

Bachelor’s degree in electrical or mechanical engineering

Job description

Hanger, Inc. is seeking a QA Engineer I to support quality assurance and product development aligned with medical device regulations (21 CFR 820, ISO 13485). Under supervision, you will assist with incoming inspections, document control, CAPA investigations, and maintaining quality records.

You will collaborate with Product Development to complete design controls and participate in validation activities while supporting calibration and equipment maintenance programs.