Quality Assurance Lead — eQMS & Regulatory Support

Vein360; Blue Ash (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

Vein360 is seeking a Quality Assurance Specialist to ensure the QMS is effective, compliant, and continuously improving. You will partner with Operations, R&D, and Regulatory to maintain product quality, support new product development (including FDA 510(k) submissions), and drive continuous improvement of internal processes.

This is a 100% on-site role in Blue Ash, OH with no relocation assistance. You will lead and participate in QA activities such as CAPAs, NCRs, and supplier quality, prepare

Qualifications

• Bachelor's or Master's degree in relevant field

Responsibilities

• Actively supports day-to-day Quality Assurance operations, ensuring compliance with internal procedures and regulatory requirements.
• Drives continuous improvement initiatives to increase efficiency, reduce costs, and strengthen compliance.
• Enhances SOPs, work instructions, and QMS workflows, including supporting the transition to an electronic QMS (eQMS).
• Conducts periodic QMS reviews and manages supplier quality activities.
• Prepares and presents data for Management Reviews.
• Ensures ongoing readiness for internal and external audits.
• Leads and resolves quality events, including nonconformances (NCRs), investigations (INVs), and CAPAs.
• Maintains quality documentation and employee training records.
• Partners with R&D and Regulatory teams to contribute QA input to design controls and regulatory submissions (e.g., FDA 510(k)).
• Leads projects and initiatives, and may mentor junior team members or interns.

Job description

Vein360 is seeking a Quality Assurance Specialist to ensure the QMS is effective, compliant, and continuously improving. You will partner with Operations, R&D, and Regulatory to maintain product quality, support new product development (including FDA 510(k) submissions), and drive continuous improvement of internal processes.

This is a 100% on-site role in Blue Ash, OH with no relocation assistance. You will lead and participate in QA activities such as CAPAs, NCRs, and supplier quality, prepare