Quality Assurance Analyst 2

Summary Quality Assurance Analyst 2 is responsible for maintaining and continuously improving the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, industry standards, and company procedures. This role serves as a key contributor to audit readiness, CAPA management, complaint investigations, regulatory submission support, management review, quality metrics, and continuous improvement initiatives, while partnering with cross-functional teams to strengthen quality culture and compliance excellence. Essential Duties and Responsibilities Quality Compliance & QMS * Support, maintain, and improve QMS processes to ensure compliance with ISO 13485, FDA QMSR, MDSAP, and company requirements. * Support Document Control, Change Control and Training System activities, ensuring timely and compliant execution. * Review and maintain quality procedures, documents, records, and training requirements. * Collaborate with cross-functional teams to ensure changes are appropriately documented, reviewed, approved, and implemented. * Support/ Drive QMS Improvement Project including Process Optimization and Document Control System enhancement. * Perform Data Analysis and Reporting to monitor QMS performance and identify improvement opportunities. * Participate in audit readiness, quality compliance and regulatory programs. Audit & Inspection Readiness * Support internal audits, external audits, walkthroughs, line walks, and mock audits. * Coordinate audit preparation, documentation, responses, and timely closure of audit findings. * Support regulatory inspections and maintain site audit readiness. * Provide guidance and coaching to process owners on compliance requirements. CAPA, Nonconformance & Complaint Management * Support investigations related to CAPA, nonconformances, deviations, and complaints. * Apply root cause analysis and problem-solving methodologies to support effective corrective and preventive actions. * Monitor and trend quality events to identify systemic issues and improvement opportunities. * Support timely closure and effectiveness verification of CAPAs. Regulatory Submission Support * Support regulatory submissions, product registrations, renewals, and change notifications. * Prepare, review, and provide quality documentation required for regulatory submissions. * Assess the quality and compliance impact of product, process, supplier, and manufacturing changes. * Support responses to regulatory agencies, notified bodies, and customer inquiries Quality Metrics & Management Review * Analyze quality data and develop metrics, dashboards, and reports. * Monitor KPI trends and recommend improvement actions. * Support Site Management Review and Quality Review meetings through data analysis and presentation of quality performance. * Utilize analytical tools such as Power BI, Excel, and other reporting platforms to support decision-making. Required Qualifications * Bachelor's Degree in Quality, Engineering, Science, or a related discipline. * Minimum 2–5 years of experience in Quality Assurance, Quality Compliance, or a regulated industry (Medical Device or Pharmaceutical preferred). * Knowledge of global medical device regulations, including FDA QMSR, ISO 13485, MDSAP, EU MDR, and applicable regional regulations. * Experience supporting regulatory inspections, audit hosting, and inspection readiness activities. * Strong understanding and hands-on experience with CAPA, Nonconformance, Change Control, and quality investigation processes. * Strong analytical, problem-solving, organizational, and communication skills. * Experience with quality metrics, data analysis, and reporting tools. * Experience in Document Control, QMS projects, or regulatory/site registration activities. * Ability to work effectively with cross-functional teams and manage multiple priorities. Preferred Qualifications * Understanding of regulatory submissions, product registrations, renewals, and change notification requirements. * Experience with Power BI, quality metrics, data visualization, and trend analysis. * Lean, Six Sigma, or other Continuous Improvement certifications. * Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Lead Auditor certification. Travel Required * Up to 25% travel, as required for audits, training, benchmarking, or cross-site collaboration. AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.