Position Summary
The Staff Quality Engineer is responsible for leading and sustaining the Corrective and Preventive Action (CAPA) process to ensure timely, effective, and compliant resolution of quality issues. This role drives root cause analysis, risk-based decision-making, and continuous improvement initiatives while maintaining adherence to internal policies, procedures, and regulatory requirements. The individual will collaborate across functions and work independently to design, implement, and optimize quality system solutions that enhance product reliability and process performance.
Responsibilities and Duties
• Support company goals, objectives, policies, and procedures to ensure alignment with quality and regulatory standards.
• Lead and manage the entire CAPA lifecycle, including initiation, investigation, action planning, implementation, and effectiveness verification.
• Serve as Subject Matter Expert (SME) for root cause analysis; provide guidance and training on structured problem-solving tools such as 5 Whys, Fishbone (Ishikawa), and Fault Tree Analysis to eliminate systemic issues.
• Perform and support risk assessments (e.g., FMEA) and integrate risk management principles into CAPA activities and sustaining engineering changes.
• Identify, prioritize, and implement proactive quality improvements to prevent recurrence of issues and enhance process robustness.
• Collect, analyze, and trend CAPA and quality system metrics to identify patterns, drive continuous improvement, and report findings to management.
• Communicate CAPA findings, progress, and outcomes effectively across cross-functional teams, ensuring transparency and accountability.
• Create, revise, and review Standard Operating Procedures (SOPs) and related documentation to maintain compliance with latest regulatory standards
• Assist with internal audits and management reviews, ensuring readiness for external inspections and regulatory audits.
Requirements
• Bachelor’s degree in an engineering or related technical discipline or equivalent
• Minimum of 7 years in Quality Assurance/Quality Engineering role within the Medical Device Industry
• Proven experience with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
• In depth knowledge of CAPA process, requirements and investigational techniques
• Working knowledge of design controls, risk management, process validation, and statistical techniques.
• Proficiency in root cause analysis tools such as Ishikawa (Fishbone) diagrams, Fault Tree Analysis, Contradiction Matrix, and 5 Whys.
• Ability to collect, review, and interpret data for trend analysis and continuous improvement.
• Self-motivated, able to work independently, and driven to achieve results with a sense of urgency.
• Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance.
• Strong written and verbal communication skills; comfortable presenting to small and large groups.
• Proficient in Microsoft Office Suite with advanced skills in Excel, PowerPoint, Visio, and Word.
Salary Range: $154,000 - $165,000
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