Senior Quality Engineer

Key Responsibilities

• Lead end-to-end CAPA processes, including initiation, investigation, implementation, and effectiveness verification
• Ensure timely closure of CAPAs in compliance with internal procedures and regulatory requirements
• Identify systemic issues and recommend preventative actions across the organization
• Track and trend CAPA data to drive continuous improvement initiatives
• Review, disposition, and manage Nonconformance Reports (NCRs)
• Collaborate cross-functionally to assess impact and determine appropriate actions
• Ensure accurate documentation and traceability of nonconformance handling
• Analyze NCR trends to identify recurring issues and improvement opportunities
• Conduct and facilitate structured root cause investigations (e.g., 5 Whys, Fishbone, Fault Tree Analysis)
• Drive cross-functional problem-solving efforts for complex quality issues
• Ensure root cause identification is data-driven, thorough, and sustainable
• Coach teams on effective problem-solving methodologies
• Support the development, implementation, and continuous improvement of the QMS
• Ensure compliance with applicable standards (e.g., ISO 9001, ISO 13485, AS9100, or industry-specific regulations)
• Lead internal audits and support external regulatory audits and inspections
• Maintain and improve quality procedures, work instructions, and documentation
• Monitor key quality metrics and report on system effectiveness
• Drive initiatives that improve product quality, reduce defects, and enhance process efficiency
• Utilize data analysis and quality tools (e.g., SPC, Pareto analysis) to identify improvement areas
• Partner with engineering, manufacturing, and operations teams to implement solutions

Qualifications

• Bachelor’s degree in Engineering, Quality, or related technical field
• 5–8+ years of Quality Engineering experience in a regulated industry (e.g., medical device, aerospace, manufacturing)
• Deep experience with CAPA and NCR systems
• Strong expertise in root cause analysis methodologies
• Hands-on experience maintaining and improving a Quality Management System (QMS)
• Working knowledge of relevant industry standards (ISO, FDA, or equivalent)
• Excellent problem-solving, analytical, and organizational skills

Key Competencies

• Structured problem-solving and investigative mindset
• Strong attention to detail and documentation discipline
• Ability to influence cross-functional teams
• Data-driven decision-making
• Continuous improvement orientation