Senior Quality Engineer - QMS & CAPA Leader

Access Vascular, Inc.; Billerica (MA); On-site; USD 93,000 - 160,000; Full time

Job summary

Access Vascular, Inc. is seeking aQuality Assurance/Quality Management professional to oversee the QMS across Operations. You will help maintain ISO 13485:2016 compliance and support CAPA, document control, and internal audits within a small, hands-on team.

The role emphasizes improving quality metrics, data analysis for risk-based decisions, and ensuring readiness for FDA inspections and Notified Body audits.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Minimum 5 years quality systems experience in a medical device manufacturing company.
• Proven track record implementing QMS per FDA 21 CFR Part 820, ISO 13485.
• Experience owning QMS end-to-end: CAPA, document control, complaints, audits.
• Strong technical writing and data analysis for validation and process capability.

Responsibilities

• Maintain and improve QMSR and ISO 13485 compliant QMS.
• Support SOPs, forms, test protocols, and controlled documents.
• Lead or support CAPA investigations, supplier quality activities, audits.
• Assist with MDR reporting, trend analysis, and FDA inspection prep.

Skills

Quality Systems

CAPA

Document Control

Internal Audits

Data Analysis

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Access Vascular, Inc. is seeking aQuality Assurance/Quality Management professional to oversee the QMS across Operations. You will help maintain ISO 13485:2016 compliance and support CAPA, document control, and internal audits within a small, hands-on team.

The role emphasizes improving quality metrics, data analysis for risk-based decisions, and ensuring readiness for FDA inspections and Notified Body audits.