Sr Quality Assurance Analyst

Summary

The Senior Quality Analyst 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 QSR/QMSR, MDSAP, and company requirements.
• Review and update quality procedures, records, and documentation.
• Support Change Control activities and drive quality system improvements.
• Participate in quality compliance initiatives and regulatory compliance programs.

Audit & Inspection Readiness

• Lead and support internal audits, external audits, walkthroughs, line walks, and mock audits.
• Coordinate audit activities, 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

• Lead investigations related to CAPA, nonconformances, deviations, and complaints.
• Perform root cause analysis and ensure effective corrective and preventive actions are implemented.
• Monitor and trend quality events to identify systemic issues and improvement opportunities.
• Ensure 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 5–8 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 QSR/QMSR, ISO 13485, MDSAP, EU MDR, and applicable regional regulations.
• Experience supporting regulatory inspections, audit hosting, and inspection readiness activities.
• Strong analytical, problem-solving, organizational, and communication skills.
• Experience with quality metrics, data analysis, and reporting tools.
• 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 certification.
• Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Lead Auditor certification are desirable.

Travel Required

• Up to 25% travel, as required for audits, training, benchmarking, or cross-site collaboration.

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