Quality Analyst

Job Summary

Quality Analyst is a full-time position responsible for ensuring compliance with regulatory requirements in new product development while collaborating with engineering teams to optimize product quality and processes.

Key Responsibilities

• Collaborate with engineers to create and assess complex change request packages
• Evaluate and analyze technical information related to production quality indicators and recommend course corrections
• Develop training materials and draft updates to quality procedures

Required Qualifications

• Bachelor's Degree in a related field or equivalent work experience
• 3 years of related experience or equivalent work experience
• Experience in a medical device, healthcare, or related environment preferred
• Proven expertise in MS Office Suite and Windchill PLM or equivalent
• Full understanding of medical device regulations (e.g., FDA and ISO13485)