Job Title: Quality Systems Engineer

Job Description

As a Quality Systems Engineer, you will own and lead the execution of quality plan actions and deliverables to establish and enforce compliance for an additional site quality management system. You will collaborate closely with business partners to provide leadership regarding Quality System certification changes, execute site audit readiness, and support quality system changes and continuous improvement activities associated with the Legal Manufacturer quality system to comply with ISO: 2016, FDA QSR/QMSR (effective Feb 2026), EU MDR, and additional regulations. Your role will involve developing strategies and implementing changes for Quality & Compliance functions within the Neurovascular business, ensuring a high state of compliance while meeting business needs.

Responsibilities

• Own and lead execution of quality plan actions and deliverables for additional site quality management system setup and enforcement of compliance.
• Collaborate with business partners to provide leadership regarding Quality System certification changes.
• Execute site audit readiness and support regulatory compliance audits through audit readiness and backroom support.
• Support quality system changes and continuous improvement activities for compliance with ISO: 2016, FDA QSR/QMSR, EU MDR, and other regulations.
• Develop and implement strategies for Quality & Compliance functions within the Neurovascular business.
• Work cross-functionally with departments such as R&D, Regulatory Affairs, Regulatory Compliance, Source Quality, Lifecycle Management, Marketing, and Supply Chain.
• Conduct Quality System and Quality Manual updates.
• Ensure compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Perform other duties as assigned.

Essential Skills

• 6+ years of experience as a Quality Engineer.
• Experience leading quality plans and QMS build-out.
• Proficiency in Windchill and ETQ systems.
• Strong knowledge in compliance, quality assurance, and regulatory affairs.
• Experience with FDA and ISO regulations.

Additional Skills & Qualifications

• Knowledge of neurovascular and medical device quality engineering.
• Experience with system integration.

Work Environment

This role is on-site, with work scheduled from Monday to Wednesday and every other Friday. The position involves working within the Neurovascular division, which is undergoing a significant transformation with the setup of a new QMS in Irvine. The team is preparing for a site qualification audit by Q1 2026, making this a critical hire to ensure compliance and operational readiness.