Quality Assurance Specialist

4 weeks ago


Billerica, Massachusetts, United States Access Vascular Inc Full time
Job Overview

The Quality Control Technician plays a vital role in ensuring the quality and integrity of our products. This position requires a high level of attention to detail and organizational skills, with a strong understanding of manufacturing documentation and Good Documentation Practices (GDP).

Key Responsibilities
  • Collaborate with manufacturing and supply chain teams to ensure production outputs meet quality, quantity, and timeliness requirements.
  • Implement and maintain effective process control systems to support product manufacturing.
  • Conduct inspections of incoming materials, in-process products, and finished goods to ensure compliance with specifications and regulatory standards.
  • Maintain detailed quality records, including lot history records, inspection records, and Nonconforming material reports.
  • Segregate, label, and control nonconforming product, maintaining a clean and organized work environment in accordance with Good Manufacturing Practices (GMP).

Requirements
  • High School Diploma
  • 5+ years hands-on Medical Device manufacturing experience in a quality-specific capacity
  • Demonstrated competency in using general mechanical inspection tools, including calipers, micrometers, pin gages, and other common measurement tools
  • Excellent written and verbal communication skills, with the ability to work independently and as part of a team

About Access Vascular
Access Vascular is a leading developer of venous access devices made from patented biomaterials, designed to reduce complications and improve patient outcomes.

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