Medical Devices QA Specialist — Travel-Ready & Detail-Driven

electroCore; Rockaway (NJ); Vor Ort; USD 55.000 - 75.000; Vollzeit

Zusammenfassung

Regulatory Jobs is seeking a Quality Assurance Specialist to support the Quality Management System (QMS) and ensure products, processes, and documentation meet regulatory requirements and quality standards.

You will assist in inspections, documentation control, complaint handling, and QMS maintenance to ensure product safety and effectiveness. The role includes training support, audits, and metrics reporting, with travel up to 20% and occasional lifting up to 35 pounds.

Qualifikationen

• 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.

Aufgaben

• Complaint Handling Support: assist 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.

Kenntnisse

Attention to detail

Documentation accuracy

Quality tools: CAPA, NCR, audits

Reading technical documents/drawings

Communication and teamwork

Ausbildung

Associate’s or Bachelor’s degree preferred

Tools

Microsoft Office

eQMS

Jobbeschreibung

Regulatory Jobs is seeking a Quality Assurance Specialist to support the Quality Management System (QMS) and ensure products, processes, and documentation meet regulatory requirements and quality standards.

You will assist in inspections, documentation control, complaint handling, and QMS maintenance to ensure product safety and effectiveness. The role includes training support, audits, and metrics reporting, with travel up to 20% and occasional lifting up to 35 pounds.