Senior/Principal Quality Systems Engineer
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Before you apply
Salary$93k – $160k
LocationAccess Vascular, Billerica, MA
Work modeon-site
Typefull-time
SeniorityLead
Experience5+ yrs
DepartmentQuality
Company size5+ people
PostedMay 26, 2026 · 5mo ago
Verified live11h ago
May no longer be actively hiring
Posted by the company on May 26, 2026100% of this company's open roles have been listed for 90+ days
At a glanceSummarised by Seekless from the posting.
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
About the role
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
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Help maintain and continuously improve our QMSR and ISO 13485-compliant QMS
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Support improvements to SOPs, work instructions, forms, test protocols, and other controlled documents
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Support document control and records management under 21 CFR Part 820
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Participate in internal audits and support external audits (FDA, supplier)
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Lead or support CAPA investigations — root cause analysis, timely closure, effectiveness verification
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Help develop quality metrics and data analysis to guide risk-based decisions
Operations & Supplier Quality
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Partner with Operations to help ensure manufacturing processes are controlled and validated
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Contribute to risk management, sterilization validation, and data integrity practices
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Support incoming inspection, nonconforming material control, and disposition
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Provide Quality Engineering input on infrastructure and expansion projects
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Support supplier qualification, evaluation, and monitoring
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Help conduct supplier audits and review corrective action responses
Post-Market Surveillance
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Support complaint handling, MDR reporting, and trend analysis
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Stay current on relevant standards and regulations and help keep the team informed
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Assist with preparation for FDA inspections and Notified Body audits
Leadership & Culture
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Help champion a proactive quality culture across a small, multidisciplinary team
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Offer quality training and mentoring where you can — we all wear a few hats here!
Qualifications
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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. .
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