Senior/Principal Quality Systems Engineer

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 designs, manufactures, and distributes sterile catheter-based, software-enabled, and electromechanical medical devices. This role helps oversee our Quality Management System and provides Quality Engineering support across Operations, working closely with a small, hands-on team under AVI's QMS and FDA QMSR requirements.

Quality Management System

• Help maintain and continuously improve our QMSR and ISO 13485-compliant QMS
• Support improvements to SOPs, work instructions, forms, test protocols, and other controlled documents
• Support 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 — root cause analysis, timely closure, effectiveness verification
• Help develop quality metrics and data analysis to guide risk-based decisions

Operations & Supplier Quality

• Partner with Operations to help ensure manufacturing processes are controlled and validated
• Contribute to risk management, sterilization validation, and data integrity practices
• Support incoming inspection, nonconforming material control, and disposition
• Provide Quality Engineering input on infrastructure and expansion projects
• Support supplier qualification, evaluation, and monitoring
• Help conduct supplier audits and review corrective action responses

Post-Market Surveillance

• Support complaint handling, MDR reporting, and trend analysis
• Stay current on relevant standards and regulations and help keep the team informed
• Assist with preparation for FDA inspections and Notified Body audits

Leadership & Culture

• Help champion a proactive quality culture across a small, multidisciplinary team
• Offer quality training and mentoring where you can — we all wear a few hats here!

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field
• Minimum of 5 years’ of quality systems experience with a medical device manufacturing company
• Proven track record with implementing, evolving, and improving medical device company quality management systems (QMS) compliant to FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971
• Demonstrated experience owning a QMS end-to-end, including CAPA, document control, complaints, internal auditing, and supplier quality
• Strong technical writing skills with the ability to produce clear, compliant documentation
• Experience with statistical techniques, sampling plans, and data analysis for validation and process capability

Compensation Commensurate With Experience

$93,000 — $160,000 USD

About Access Vascular

Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .