Senior Quality Systems Engineer - Devices (QMS Lead)

Accessvascular; Billerica (MA); On-site; USD 93,000 - 160,000; Full time

Job summary

Access Vascular, based in Massachusetts, seeks a Quality Engineer to oversee our QMS and provide quality engineering support across a small, hands-on team. You will drive compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971, lead CAPA activities, enhance documentation and risk management, and partner with operations and suppliers to ensure validated, controlled processes.

This role offers growth within a collaborative culture and exposure to post-market surveillance, audits, and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 5+ years' quality systems experience in medical device manufacturing.
• Experience implementing QMS per 21 CFR 820, ISO 13485, ISO 14971.
• End-to-end QMS ownership including CAPA, docs, complaints, audits, supplier quality.
• Strong technical writing for compliant documentation.
• Experience with statistics, sampling, data analysis for validation.

Responsibilities

• Maintain and improve QMSR and ISO 13485-compliant QMS
• Improve SOPs, work instructions, forms, test protocols, and documents
• Document control and records management under 21 CFR Part 820
• Participate in internal audits and support external audits (FDA, supplier)
• Lead or support CAPA investigations and verification
• Develop quality metrics and data analysis for risk-based decisions
• Partner with Operations to control and validate manufacturing processes
• Contribute to risk management, sterilization validation, and data integrity
• Support incoming inspection, nonconforming material control, and disposition
• Provide QA input on infrastructure and expansion projects
• Support supplier qualification, evaluation, monitoring
• Conduct supplier audits and review corrective actions
• Support complaint handling, MDR reporting, and trend analysis
• Stay current on standards/regulations and inform the team
• Assist with FDA inspections and Notified Body audits
• Help champion proactive quality culture and mentoring

Skills

Quality management

CAPA

Document control

Internal auditing

Data analysis

Technical writing

Regulatory knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Access Vascular, based in Massachusetts, seeks a Quality Engineer to oversee our QMS and provide quality engineering support across a small, hands-on team. You will drive compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971, lead CAPA activities, enhance documentation and risk management, and partner with operations and suppliers to ensure validated, controlled processes.

This role offers growth within a collaborative culture and exposure to post-market surveillance, audits, and