Document Control Specialist

Access Vascular(26 days ago)

Billerica, MAOnsiteFull TimeMedior$65,000 - $85,000Quality Assurance

About this role

Responsible for creation and maintenance of medical device design and quality documentation and for managing the Quality Management System (QMS), including controlled documents, records, and associated processes. Works with technical teams to establish documentation standards, maintain a central repository, and support the implementation and execution of the electronic documentation system. The role also supports continuous improvement of QMS procedures and assists with internal and external audits.

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Required Skills

Document Control
Quality Documentation
Change Control
Records Management
QMS Management
Electronic Documentation
Audit Support
Training Metrics
Regulatory Compliance
Data Entry

+11 more

Qualifications

Associate Degree in Science or Technical Discipline

About Access Vascular

accessvascularinc.com

Access Vascular develops novel hydrophilic biomaterial vascular access devices, including a midline catheter (HydroMID) and peripherally inserted central catheter (PICC). Their biomaterial is engineered to significantly reduce complications — data cited show up to 6x fewer complications with HydroMID and 99.99% less bacterial adhesion versus polyurethane in a blood-loop model. The company targets hospitals and infusion providers to improve patient outcomes and lower infection and complication rates across acute and home-care settings. Clinical evidence and material innovation are positioned as their core differentiators in transforming vascular access outcomes.