Project Coordinator - Product Change Control

333 Lakeside Drive,, United States | Posted on 06/01/2026 Our client, a world leader in life sciences and biotechnology, is looking for a “Project Coordinator - Product Change Control” based outof Foster City, CA. Job Duration:Long Term Contract(Possibility Of Extension) PR: $100/Hr on W2 with benefits Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K Our client, a leading biotechnology company, is seeking a Project Coordinator to support commercial combination products throughout the product lifecycle. This role will be responsible for managing change control activities, maintaining risk management documentation, coordinating post-market surveillance reporting, and partnering with cross-functional teams to ensure product quality and supply continuity. Key Responsibilities Initiate, coordinate, and close change control records for product, process, and manufacturing changes. Coordinate implementation of approved changes across manufacturing sites and ensure timely closure of change records. Prepare and maintain post-market surveillance reports and annual risk management summaries. Update and maintain risk management files in compliance with applicable regulations. Support complaint investigations, root cause analysis, and documentation activities. Collaborate with Engineering, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external partners to drive project execution. Maintain documentation within quality systems and ensure compliance with regulatory requirements. Track project timelines, deliverables, and change implementation activities. Required Qualifications Bachelor's degree in Engineering, Life Sciences, Quality, or a related discipline. 3–5 years of experience in medical device, combination product, pharmaceutical, or regulated manufacturing environments. Experience managing change controls, engineering changes, or product lifecycle activities. Knowledge of FDA, ISO 13485, cGMP, and medical device regulations. Experience with risk management activities, including FMEA and risk file maintenance. Familiarity with complaint investigations, CAPA, and quality systems processes. Strong organizational, project management, and documentation skills. Excellent communication and cross-functional collaboration abilities. Preferred Qualifications Experience supporting drug-device combination products. Experience with Design Controls, Design History Files (DHF), and product development documentation. Hands-on experience with Veeva Vault, Agile PLM, Windchill, TrackWise, MasterControl, or similar systems. Knowledge of post-market surveillance and risk management reporting. Key Skills Change Control | Design Controls | Risk Management | ISO 13485 | FDA 21 CFR Part 820 | cGMP | CAPA | Complaint Investigation | DHF | FMEA | Post-Market Surveillance | Veeva Vault | Project Management | Cross-Functional Collaboration | Combination Products | Medical Devices | Pharmaceutical Operations #J-18808-Ljbffr Dawar Consulting, Inc.