Senior Quality Systems Engineer

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 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. .