What are the responsibilities and job description for the Quality Engineer (CAPA) Only on W2 position at Grove Technical Resources, INC?
Job Title : CAPA Engineer
Location : Princeton, NJ
Duration : 12 Months
Job Summary :
The CAPA Engineer will play a critical role in maintaining and improving the quality management system by ensuring effective resolution of quality issues and compliance with regulatory requirements. This individual will lead and support the Corrective and Preventive Actions (CAPA) process, collaborating cross-functionally to identify root causes, implement corrective actions, and verify their effectiveness.
- Lead CAPA investigations for non-conformances, complaints, and audit findings, ensuring compliance with FDA, ISO 13485, and other applicable regulations.
- Facilitate root cause analysis using tools like Fishbone Diagrams, 5-Why, and Failure Mode and Effects Analysis (FMEA).
- Define and implement corrective and preventive actions to address identified issues.
- Ensure CAPA actions are completed within specified timelines and monitor their effectiveness.
- Maintain CAPA documentation in accordance with regulatory requirements and company procedures.
- Support internal and external audits by providing CAPA-related documentation and responses.
- Partner with Quality, R&D, Manufacturing, and Supply Chain teams to address quality issues and improve processes.
- Provide training and guidance to teams on CAPA processes and best practices.
- Identify and implement opportunities for process improvement to enhance product quality and compliance.
- Participate in Quality Management System (QMS) reviews and suggest enhancements to CAPA procedures.
- Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and EUMDR requirements.
- Experience with CAPA systems, root cause analysis tools, and quality management software.
- Strong analytical skills and attention to detail.
- Excellent communication and project management skills.
- Certification in Six Sigma, Lean, or Quality Management (e.g., ASQ Certified Quality Engineer) is a plus.
- Familiarity with risk management standards (ISO 14971).
- Experience working with electronic document management systems (EDMS).
- Proficiency in statistical tools for quality analysis (e.g., Minitab, JMP).
