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. 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.

 

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!

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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