Quality Improvement Specialist

Job Summary

A company is looking for a Sr Specialist, Quality & Continuous Improvement.

Key Responsibilities

• Develop, implement, and maintain an efficient Quality Management System (QMS) compliant with regulations and standards
• Lead internal and supplier audits, prepare for external audits, and facilitate root cause analysis for quality improvements
• Plan and execute continuous improvement initiatives in collaboration with cross-functional teams

Required Qualifications

• Bachelor's degree in Engineering, Science, Quality Management, or a related field
• Minimum of 8 years of experience in quality management within healthcare technology or life sciences
• Certification or formal training in Lean Manufacturing/Six Sigma is an asset
• Experience in leading continuous improvement initiatives and applying relevant tools and techniques
• Understanding of standards like ISO13485 and regulatory requirements such as 21 CFR Part 820 preferred