Senior/Principal Quality Systems Engineer
Apply on Access Vascular's site
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
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. .
About Access Vascular
Access Vascular is a medical device company that develops novel bulk hydrophilic-based devices to improve venous access.