Fda Auditor Jobs in Virginia (NOW HIRING)

Position Description: CGI Federal has an exciting opportunity for Quality Assurance Managers/Specialists within our Intel sector advancing the national security mission through cutting edge technology. You must have a passion for keeping pace with rapidly evolving technology advancements and leveraging your knowledge on a highly collaborative team to deliver state-of-the-art capabilities. The Quality Assurance Manager/Specialist oversees quality standards to ensure a company's products or services meet safety and performance requirements. They inspect processes, track defects, and collaborate with teams to implement fixes. This role bridges the gap between production standards and customer satisfaction. CGI Federal is growing its high-performance team whose members share a passion for building high-quality, scalable, advanced IT solutions in a collaborative, fast-paced, outcome-driven mission. This position is located in our Arlington office; however, a hybrid working model is acceptable. Your future duties and responsibilities: Key Responsibilities (Entry Level)
• Inspection: Test and evaluate products or services to ensure they meet internal company benchmarks.
• Documentation: Record and maintain quality reports, malfunction logs, and audit data.
• Problem Solving: Identify the root cause of product defects or process errors.
• Collaboration: Partner with production, engineering, or development teams to resolve identified issues.
• Compliance: Ensure all processes adhere to relevant legal and industry regulations. Key Responsibilities (Junior Level)
• Product Testing & Inspection: Execute routine inspections and tests on raw materials and finished goods to identify defects.
• Documentation & Reporting: Maintain accurate quality assurance records, draft Standard Operating Procedures (SOPs), and log non-compliance reports.
• Process Monitoring: Track product performance metrics, monitor manufacturing stages, and highlight areas where processes deviate from predefined standards.
• Defect Resolution: Investigate the root cause of quality issues and collaborate with production, engineering, or development teams to implement corrective actions.
• Compliance: Ensure adherence to company policies, industry regulations, and safety standards. Key Responsibilities (Mid-Level)
Quality Assurance & Compliance
• Execute and enforce requirements within the Quality Management System (QMS) for commercial and developmental programs.
• Manage non-conformances, including deviations, CAPA (Corrective and Preventive Actions), and change controls.
• Conduct internal audits, ensure adherence to regulatory requirements (e.g., FDA, ISO 9001), and assist in third-party audits.
Data Analysis & Process Improvement
• Perform Root Cause Analysis (RCA) and failure mode investigations to resolve systemic quality defects.
• Track, monitor, and report key quality metrics (e.g., First Pass Yield, Cost of Poor Quality).
• Utilize Statistical Process Control (SPC) and FMEA (Failure Mode and Effects Analysis) to evaluate and improve manufacturing or service processes.
Operational Execution & Leadership
• Provide independent oversight of commercial manufacturing or service delivery to verify compliance with predefined criteria.
• Exercise stop-work authority when critical nonconformances or systemic failures are identified.
• Collaborate with engineering, supply chain, and production teams to establish quality standards for incoming materials and final output.
• Train and mentor team members, ensuring organization-wide awareness of Good Manufacturing Practices (GMP) and Standard Operating Procedures. Key Responsibilities (Senior Level)
QMS Governance: Formulate, implement, and maintain Quality Manuals aligning with highly regulated frameworks (e.g., ISO 9001, AS9100, or GxP/FDA).
Advanced Compliance & Auditing: Direct internal, external, and supplier audit programs. Lead comprehensive Root Cause Analysis and Corrective/Preventive Actions (CAPA) to mitigate production and software defects.
Statistical Process Control (SPC): Utilize advanced statistical modeling and data analytics to measure and stabilize operational variance.
Risk-Based Testing: Oversee both manual and automated validation and testing protocols. Manage risk thresholds during product release cycles.
Cross-Functional Leadership: Serve as the strategic bridge between engineering, development, legal, and operational teams to embed quality control into every stage of the product lifecycle.
Supply Chain Interfacing: Define strict quality metrics for raw materials, audit vendor facilities, and collaborate with external partners on technical resolution.
Budget & Team Management: Manage departmental budgets, build training programs for QA personnel, and execute performance evaluations. Key Responsibilities (SME Level)
Strategic Quality Leadership & Systems Management
• Design & Execution: Architect, deploy, and continuously optimize enterprise-wide Quality Management Systems (QMS), ensuring they adhere to rigorous standards like ISO 9001, AS9100, or FDA/GMP regulations.
• KPI Tracking & Reporting: Develop quality dashboards that track metrics like defect rates, first-pass yield, and scrap costs, presenting clear data-driven strategies to the executive leadership team.
• Budget & Resource Allocation: Manage the departmental budget, allocating resources efficiently to meet operational and financial objectives.
Compliance, Auditing & Risk Mitigation
• Regulatory Alignment: Ensure all operational, supply chain, and production processes meet regional, national, and international legal mandates.
• Audit Mastery: Lead internal audit programs and manage external inspections from governing bodies or certification agencies.
• Risk Management: Implement advanced risk-assessment models to proactively identify vulnerabilities and implement preventative frameworks.
Advanced Root Cause Analysis (RCCA) & Problem Solving
• Defect Resolution: Lead cross-functional teams in complex Root Cause Analysis and Corrective/Preventative Action (CAPA) implementations for recurring non-conformances.
• Statistical Process Control: Apply rigorous statistical methods and Six Sigma/Lean methodologies to continuously improve manufacturing or development processes.
• Continuous Improvement: Champion a culture of quality where defects are prevented rather than merely detected, reducing scrap, rework, and waste.
Supplier & Customer Integration
• Supply Chain Quality: Collaborate with procurement and suppliers to establish strict raw material specifications, auditing vendors to guarantee incoming quality.
• Customer Advocacy: Investigate escalated customer complaints, analyze warranty claims, and translate field feedback into actionable design and production improvements. Team Mentorship & Culture Development
• Talent Development: Supervise, mentor, and evaluate QA engineers, inspectors, and technicians.
• Training Programs: Devise and deliver comprehensive training protocols to ensure quality expectations are deeply understood across all operational departments. Required qualifications to be successful in this role: All roles require an active TS/SCI with Poly Entry Level:
• Education: o High School Diploma/GED with 4 years of relevant experience,
o Associates Degree with 2 years of relevant experience, o or Bachelor's Degree with 0 years of relevant experience
• Attention to Detail: Ability to spot minor defects or inconsistencies.
• Communication: Clearly explain complex quality problems to team members and management.
• Analytical Skills: Review data and metrics to spot trends.
• Experience: Familiarity with quality assurance methodologies and basic workplace tools. Junior Level/Moderate:
• Education: o High School Diploma/GED with 6 years of relevant experience,
o Associates Degree with 4 years of relevant experience, o Bachelor's Degree with 2 years of relevant experience, o or Masters Degree with 0 years of relevant experience
• Certifications: Certifications like Six Sigma or credentials from the American Society for Quality (ASQ) are highly desirable.
• Essential Skills: Strong attention to detail, excellent written and verbal communication, and a solid grasp of data analysis and quality metrics. Mid-Level/Complex:
• Education: o High School Diploma/GED with 8 years of relevant experience,
o Associates Degree with 6 years of relevant experience, o Bachelor's Degree with 4 years of relevant experience, o or Masters Degree with 2 years of relevant experience,
o or PhD with 0 years of relevant experience
• Certifications: Certifications such as ASQ (American Society for Quality), Six Sigma Green/Black Belt, or Certified Quality Engineer (CQE) are highly preferred.
• Core Competencies: Strong root-cause analysis, attention to detail, robust cross-functional communication, and technical writing skills. Senior Level/Exceptionally Complex:
• Education: o High School Diploma/GED with 10 years of relevant experience,
o Associates Degree with 8 years of relevant experience, o Bachelor's Degree with 6 years of relevant experience, o or Masters Degree with 4 years of relevant experience,
o or PhD with 2 years of relevant experience
• Certifications: Six Sigma Black Belt, ASQ (American Society for Quality) certifications, or specialized regulatory credentials preferred.
• Technical Skills: Mastery of QMS software, ERP/MRP integration, and automated testing frameworks.
• Competencies: Exceptionally strong analytical skills, critical thinking, and the ability to clearly translate complex data dashboards for senior executives. SME Level/Exceptionally Complex:
• Education: o High School Diploma/GED with 12 years of relevant experience,
o Associates Degree with 10 years of relevant experience, o Bachelor's Degree with 8 years of relevant experience, o or Masters Degree with 6 years of relevant experience,
o or PhD with 4 years of relevant experience
• Certifications: Six Sigma Black Belt, ASQ Certified Quality Engineer (CQE), or Certi