QA/QC Engineer I: Medical Device Quality & Validation

Hanger Fabrication Network; Phoenix (AZ); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive compensation

Paid holidays

401k plan

Medical, dental, vision

Relocation assistance

Job summary

Hanger, Inc. is seeking a QA/QC Engineer I in Phoenix, AZ to support quality assurance and product development for medical devices in accordance with 21 CFR 820, ISO 13485, and ISO 14971.

Under supervision, you will assist with incoming inspections, documentation, CAPA activities, and product reviews to ensure conformance to specifications. The role involves supporting document control, maintaining quality records, and participating in design control tasks for new and existing product lines, all

Qualifications

• Bachelor's degree in electrical or mechanical engineering is required.
• Experience in medical device industry or quality assurance is preferred.
• Familiarity with 21 CFR 820, 21 CFR Part 11, and ISO 13485 is beneficial.

Responsibilities

• Follow established procedures for QA/QC and regulatory compliance.
• Assist with incoming inspection, product release, and CAPA documentation.
• Support document control, quality records, and traceability data entry.
• Contribute to validation activities (IQ/OQ/PQ) and calibration programs.

Skills

Quality assurance

Regulatory awareness

Education

Bachelor's degree in electrical or mechanical engineering

Job description

Hanger, Inc. is seeking a QA/QC Engineer I in Phoenix, AZ to support quality assurance and product development for medical devices in accordance with 21 CFR 820, ISO 13485, and ISO 14971.

Under supervision, you will assist with incoming inspections, documentation, CAPA activities, and product reviews to ensure conformance to specifications. The role involves supporting document control, maintaining quality records, and participating in design control tasks for new and existing product lines, all