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.

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