Job Description
We are seeking a Quality Systems Engineer who will own and lead the execution of quality plan actions and deliverables for the setup and enforcement of compliance with an additional site quality management system. This role involves collaborating closely with business partners to lead Quality System certification changes, executing site audit readiness, and supporting quality system changes and continuous improvement activities to comply with relevant regulations.
ResponsibilitiesLead the execution of quality plan actions and deliverables for site quality management system setup and compliance enforcement.Collaborate with business partners to provide leadership for Quality System certification changes.Execute site audit readiness and support regulatory compliance audits with thorough audit readiness and backroom support.Support 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.Develop strategies and implement changes for Quality & Compliance functions to maintain a high state of compliance and meet business needs.Work cross-functionally with departments such as R&D, Regulatory Affairs, Regulatory Compliance, Source Quality, Lifecycle Management, Marketing, and Supply Chain to implement changes.Conduct Quality System and Quality Manual updates.Ensure personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures.Perform other duties as assigned.Essential SkillsMinimum of 4 years of experience in Quality.Experience in quality site system setup and manufacturing implementation.Proficiency in Windchill and ETQ systems.Experience in neurovascular quality engineering.Knowledge of FDA regulations, Quality management, ETQ Reliance, ISO standards, system integration, audit preparation, and regulatory compliance.Additional Skills & QualificationsExperience with Windchill QMS and/or ETQ is a must.Strong skills in Compliance, Quality Assurance, and Regulatory Affairs.Knowledge of working with and executing a quality plan and updating procedures (SOPs).Work Environment
This role is on-site at the Irvine location, Monday to Wednesday and every other week. The work environment involves supporting the transition of the quality department and manufacturing from Florida to Irvine, ensuring readiness for a site qualification audit by Q1 2026. The Neurovascular division, part of a larger organization focused on innovative solutions for stroke prevention and treatment, operates across both pharma and medtech sectors and is undergoing significant transformation.
Pay and Benefits
The pay range for this position is $55.00 - $60.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Irvine,CA.
Application Deadline
This position is anticipated to close on Aug 20, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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