Specialist - Quality Assurance
electroCore Inc•Rockaway, NJ
•Onsite
About The Position
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.
Requirements
- Associate’s or Bachelor’s degree preferred
- 0–3 years of experience in a regulated environment (medical device preferred)
- Experience with ISO 13485 or FDA regulations is a plus
- 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.
Responsibilities
- 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)
- Assist with the compiling and reporting of quality and regulatory metrics
- Ensure training records are maintained and up to date
- Support onboarding and training documentation for new employees
- Other duties may be assigned by manager.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
