Quality Compliance Specialist

Job Description: Quality Compliance SpecialistWork Location: Irvine, CA 92614 (Hybrid – 2 to 3 days onsite initially) Duration: 12 Months (Possible extension up to 18 months) Work Arrangement: Hybrid (Must be local to Irvine, CA)Position SummaryThe Quality Compliance Specialist is responsible for managing the end-to-end complaint handling process. This includes assessing incoming information to determine complaint status, evaluating events for Medical Device Reporting (MDR) eligibility, and ensuring timely submission of regulatory reports to the FDA.Key ResponsibilitiesComplaint Management: Evaluate and process customer complaints, ensuring all required information is gathered and documented.Regulatory Reporting: Determine reportability for Medical Device Reporting (MDR); prepare and submit electronic MDR reports to the FDA.Cross-Functional Collaboration: Research and seek input from Product Safety, Engineering, and Manufacturing to facilitate investigations.Documentation: Summarize findings from product analysis, imaging reviews, and Instructions for Use (IFU) to formulate sound conclusions.Communication: Manage customer expectations throughout the investigation process and prepare final correspondence.Process Improvement: Identify bottlenecks and lead projects to improve quality compliance procedures and practices.Meetings: Assist in planning and running weekly meetings with internal stakeholders to identify root causes and resolve open action items.Required Qualifications & Experience:Experience: 2–4 years of experience in Quality Compliance or Complaint Handling. (Senior candidates with 5–6+ years are also welcome).Industry: Experience in Medical Device (Class III preferred).Regulatory Knowledge: Strong understanding of Medical Device Reporting (MDR) regulations, FDA reporting requirements, and ISO standards.Technical Skills: High proficiency in MS Office Suite (especially Excel) and general computer literacy.Documentation: Solid knowledge of Good Documentation Practices (GDP) and medical terminology/human anatomy.Education: Bachelor’s degree in a related field is preferred. (Equivalent professional experience will be considered for strong candidates without a degree).Soft Skills & Success Metrics:Independence: Ability to ramp up quickly and manage cases independently within the first 90 days.Communication: Excellent written and verbal skills for interacting with healthcare professionals and internal business units.Problem Solving: Strong investigative and critical thinking skills with high attention to detail.Adaptability: A positive attitude with the ability to manage competing priorities in a fast-paced environment.Additional Information:Onboarding: In-depth training will be provided during the first 30 days, requiring a more frequent onsite presence (2-3 days per week).Interview Process: Two rounds of remote panel interviews.Equipment: Necessary IT equipment will be provided.