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Specialist - Quality Assurance
electroCore, Inc.
- Rockaway, New Jersey, United States
- Rockaway, New Jersey, United States
Über
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 systemsStrong 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
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Sprachkenntnisse
- English
Hinweis für Nutzer
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