QA & Compliance Associate — Medical Devices, 20% Travel

electroCore, Inc.; Rockaway (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

electroCore, Inc. is seeking a Quality Assurance Specialist in New Jersey to support the Quality Management System and ensure product safety and effectiveness. The role covers complaint handling, inspections, and training support, with exposure to ISO 13485 or FDA regulations.

The ideal candidate has 0–3 years in a regulated environment and strong documentation skills. A Bachelor’s degree is preferred, and familiarity with eQMS and standard quality tools is a plus.

Qualifications

• 0–3 years in a regulated environment (medical devices preferred).
• Experience with ISO 13485 or FDA regulations is a plus.
• Experience with CAPA, NCR, and audits is desirable.

Responsibilities

• Support handling of customer complaints and intake documentation.
• Assist with intake, documentation, and processing of customer complaints.
• Support complaint investigations and ensure timely closure.
• Help ensure complaints are evaluated for reportability.
• Perform incoming, in-process, and final inspections of components and finished devices.
• Verify product conformity to specifications, drawings, and procedures.
• Record inspection results and ensure proper documentation in batch records (DHRs).
• Maintain training records and support onboarding documentation.
• Assist with compiling quality and regulatory metrics.

Skills

Attention to detail

Documentation accuracy

CAPA/NCR/audits

Reading technical drawings

Organizational skills

Time management

Communication & teamwork

Education

Associate’s or Bachelor’s degree preferred

Tools

Microsoft Office

eQMS

Quality management software

Job description

electroCore, Inc. is seeking a Quality Assurance Specialist in New Jersey to support the Quality Management System and ensure product safety and effectiveness. The role covers complaint handling, inspections, and training support, with exposure to ISO 13485 or FDA regulations.

The ideal candidate has 0–3 years in a regulated environment and strong documentation skills. A Bachelor’s degree is preferred, and familiarity with eQMS and standard quality tools is a plus.