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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