Medical Device Quality Operations Specialist I

HonorVet Technologies; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

HonorVet Technologies in Irvine, CA is seeking a Quality Operations Specialist I to review and investigate customer complaints, document results, and support manufacturing line quality through SAP and cross-functional collaboration.

The ideal candidate has 2–5 years of regulatory and quality system experience in medical devices, strong Excel skills, and a Bachelor's degree in Engineering. This 12‑month contract involves improving processes and ensuring FDA, ISO 13485 compliance.

Qualifications

• Knowledge of regulatory reporting requirements for medical devices (MDR, Vigilance).
• Experience with medical device complaint files and quality records.
• Familiarity with FDA regulations (21 CFR 820, 803) and ISO 13485; strong documentation.

Responsibilities

• Review and investigate assigned technical and clinical customer complaints.
• Perform technical investigations and document results per procedures and timelines.
• Supports quality functions pertaining to manufacturing line; uses SAP.
• Troubleshoot customer returned devices and manufacturing nonconformities; document outcomes.
• Assist complaint intake through review and verification of initial coding.
• Monitor post-market performance via evaluation of complaints, service calls, and rejections.
• Ensure corrective actions address root causes of trends; coordinate improvements with teams.
• Ensure compliance with Quality System policies and FDA/ISO requirements.

Skills

Regulatory knowledge

Communication skills

FDA/ISO knowledge

Documentation skills

Education

Bachelor's Degree in Electrical or Mechanical Engineering

Other Engineering or Natural Science degree with relevant experience

Tools

Excel

Job description

HonorVet Technologies in Irvine, CA is seeking a Quality Operations Specialist I to review and investigate customer complaints, document results, and support manufacturing line quality through SAP and cross-functional collaboration.

The ideal candidate has 2–5 years of regulatory and quality system experience in medical devices, strong Excel skills, and a Bachelor's degree in Engineering. This 12‑month contract involves improving processes and ensuring FDA, ISO 13485 compliance.