For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.com with the following: 1) word copy of resume 2) 2-3 professional references 3) 4-5 brief bullet points highlighting technical qualifications  Description Job Title: Quality Engineer / Quality Lead – QMS Separation & Harmonization (Long Term Contract) Location: Irvine, CA – Hybrid/ Onsite (Preferred) Remote option available for the right candidate, supporting Pacific Time, Eastern Time and Internationally Start Date: Late March Duration: 14-month contract with potential for extension ________________________________________ Position Summary We are seeking an experienced Quality Engineer / Quality Lead (6–10 years) to support the separation of a medical device company from a parent organization and the transition to a stand alone Quality Management System (QMS). This role requires a strong understanding of how QMS elements interact across functions and the ability to execute an existing transition and harmonization strategy. The ideal candidate is a hands on “doer”, comfortable assessing procedures, implementing change, executing document migrations, and driving day to day quality system activities rather than defining enterprise level strategy. ________________________________________ Key Responsibilities QMS Transition & Harmonization • Develop a deep, working understanding of the current Quality Management System and support the transition out of the parent quality system into a stand alone QMS. • Evaluate existing procedures, work instructions, records, and quality system elements to determine what should be retained, modified, or removed as part of the separation. • Execute quality system harmonization and improvement activities in alignment with defined project plans and quality plans. PLM / Document Migration (Windchill) • Serve as Quality Lead working with the Windchill PLM team to map and execute the migration of all quality system document types into a new system container, including: o Procedures o Work Instructions o Parts o Specifications o Quality Records • Ensure proper document structure, metadata, traceability, and compliance throughout the migration. Change Management & Implementation • Support the development and hands on implementation of change management processes required to enable QMS separation. • Execute change controls, document updates, approvals, and training impacts associated with quality system changes. Project Execution & Monitoring • Lead day to day quality execution activities tied to the overall QMS separation project. • Monitor project progress, identify issues or risks, and recommend and implement corrective actions. • Maintain project schedules and provide regular status updates to Quality and project stakeholders. ________________________________________ Required Qualifications • 6–10 years of Quality Engineering experience in the medical device industry • B.S.E. or related field of study • Strong working knowledge of QMS structure, interactions, and execution • Hands on experience with: o QMS transitions, system separations, or major quality system changes o Document control and change management o PLM systems (Windchill experience strongly preferred) • Solid understanding of global medical device regulatory requirements • Ability to work independently, manage details, and drive tasks to completion Skills windchill, quality management system, EU, EUMDR, Quality assurance, qms, design transfer, Engineering, change management, quality engineering, work instruction, QMS Implementation, medical device, traceability Top Skills Details windchill,quality management system Additional Skills & Qualifications Desired Candidate Profile • A hands on executor, not a high level strategist • Comfortable implementing decisions and direction defined by leadership • Able to work cross functionally with Quality, Regulatory, IT/PLM, and business teams • Thrives in fast paced environments with shifting priorities during organizational change Experience Level Expert Level Job Type & Location This is a Contract position based out of Irvine, CA. Pay and Benefits The pay range for this position is $70.00 - $71.11/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 Feb 27, 2026. 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.