Specialist - Quality Assurance

electroCore, Inc.; Rockaway (NJ); Vor Ort; USD 60.000 - 90.000; Vollzeit

Zusammenfassung

electroCore, Inc. is seeking a Quality Assurance Specialist to support the QMS by ensuring products, processes, and documentation meet regulatory requirements and quality standards.

You will assist in inspections, documentation control, complaint handling, and quality system maintenance to ensure product safety and effectiveness. The role involves handling customer complaints, conducting investigations, and maintaining training records, with travel up to 20%.

Qualifikationen

• 0–3 years of experience in a regulated environment (medical device preferred).
• Experience with ISO 13485 or FDA regulations is a plus.
• Associate’s or Bachelor’s degree preferred.

Aufgaben

• Support complaint handling, intake, documentation, and processing of customer complaints.
• Assist with complaint investigations and ensure timely closure.
• Verify product conformity through inspections and documentation in batch records (DHRs).
• Assist compiling and reporting quality and regulatory metrics.
• Support onboarding and training documentation for new employees.

Kenntnisse

Detail oriented

Documentation accuracy

CAPA/NCR/Audits

Read/interpret technical documents

Organization & time management

Microsoft Office / eQMS

Communication & teamwork

Ausbildung

Associate or Bachelor’s degree preferred

Tools

Microsoft Office

eQMS

Jobbeschreibung

Description

The Quality Assurance Specialist supports the Quality Management System (QMS) by ensuring products, processes, and documentation comply with applicable regulatory requirements, internal procedures, and quality standards. This role assists in inspections, documentation control, complaint handling, and quality system maintenance to ensure product safety and effectiveness.

Primary Job Responsibilities

• Complaint Handling Support
• Assist with intake, documentation, and processing of customer complaints
• Support complaint investigations and ensure timely closure
• Help ensure complaints are evaluated for reportability

Inspection and Testing

• 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)

Assist with the compiling and reporting of quality and regulatory metrics

Training Support

• Ensure training records are maintained and up to date
• Support onboarding and training documentation for new employees

Other duties may be assigned by manager.

Requirements

Qualifications

Education

• Associate’s or Bachelor’s degree preferred

Experience

• 0–3 years of experience in a regulated environment (medical device preferred)

Experience with ISO 13485 or FDA regulations is a plus

Skills and Competencies

• Strong attention to detail and documentation accuracy
• Familiarity with quality tools (CAPA, NCR, audits)
• Ability to read and interpret technical documents and drawings
• Good organizational and time management skills
• Proficiency in Microsoft Office and/or eQMS systems
• Strong communication and teamwork skills.

Travel and Other Physical Demands

• Travel of approximately 20%
• Must be able to occasionally lift and move items weighing up to 35 pounds