Quality Assurance Compliance Specialist

Location Irvine (Onsite or Hybrid as applicable) Employment Type Contract Duration 12+ Months This position complies with applicable wage transparency laws. The pay rate listed represents a good-faith estimate based on the role, experience level, and location. Actual compensation may vary based on qualifications, skills, and experience. Job Summary The Quality Compliance Specialist is responsible for evaluating customer complaints related to medical devices, determining reportability, and ensuring compliance with applicable regulatory requirements, including those set by the U.S. Food and Drug Administration. This role collaborates with cross-functional teams to investigate issues, identify root causes, and support quality and compliance initiatives that contribute to product safety and effectiveness. Responsibilities Review and assess customer complaints to determine if they meet complaint criteria and regulatory reporting requirements Conduct investigations in collaboration with Product Safety, Engineering, Manufacturing, and Quality teams Prepare and submit Medical Device Reports (MDRs) in compliance with regulatory standards Analyze findings, including product evaluations, documentation, and labeling, to determine root cause Communicate investigation results and resolutions to customers in a clear and professional manner Lead or participate in meetings to discuss complaint trends, root cause analysis, and corrective actions Identify opportunities for process improvements and support implementation of solutions Maintain accurate and compliant documentation in accordance with Good Documentation Practices (GDP) Required Qualifications Bachelor’s degree or equivalent in a related field 2–4 years of experience in quality, compliance, or complaint handling within medical device, healthcare, or a related regulated industry Knowledge of Medical Device Reporting (MDR) regulations and regulatory compliance requirements Familiarity with Good Documentation Practices (GDP) Strong analytical, problem-solving, and investigative skills Excellent written and verbal communication skills Ability to manage multiple priorities in a fast-paced environment Proficiency in Microsoft Office Suite Work Requirements Ability to work independently on complex assignments with attention to detail and accuracy Ability to collaborate effectively with cross-functional teams and stakeholders Ability to handle confidential information with discretion Regular use of standard office equipment and computer systems #J-18808-Ljbffr L&T Technology Services