Job Title: Quality Systems EngineerJob 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. Pay and Benefits The pay range for this position is $60.00 - $75.00/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 Jul 28, 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. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.