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 (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations. Our dedicated recruitment team focuses on delivering qualified life sciences and pharmaceutical professionals efficiently while ensuring quality, compliance, and client satisfaction.

Job Title: Quality Operations Specialist I

Location: Irvine, CA

Contract Length: 12 months with potential extension

Major Accountabilities:

• Review and investigate assigned technical and clinical customer complaints.
• Perform technical investigations and document results per established procedures and timelines.
• Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
• Assist complaint intake group through review and verification of initial complaint coding.
• Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections.
• Ensure that appropriate corrective actions are implemented to address the root cause of trending issues.
• Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc).
• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices

Qualifications:

• Years' Experience: 2-5 years
• Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);
• Familiarity with medical device complaint files and quality records;
• Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;
• Strong computer skills (including Excel)
• Demonstrated written and verbal communication skills
• Bachelor's Degree in Electrical Engineering or Mechanical Engineering HIGHLY PREFERRED.
• Other Engineering degrees or Natural Science degrees to be considered with RELEVANT experience in MEDICAL DEVICE TROUBLESHOOTING.