Quality Engineer

Job Summary:

• Seeking a Quality Engineer with combined experience in supplier quality and manufacturing quality within the medical device industry.
• The role will support supplier qualification, manufacturing process controls, and regulatory compliance to ensure product quality and continuous improvement in a regulated environment.

• Manage supplier qualification, audits, and performance monitoring activities
• Support manufacturing operations with quality oversight and issue resolution
• Lead investigations, CAPA, SCAR, and nonconformance activities
• Ensure compliance with FDA and ISO regulatory requirements
• Participate in risk assessments and continuous improvement initiatives
• Support internal and external audits and regulatory inspections

• Bachelor's degree in Engineering or related field
• 3+ years of quality engineering experience in medical device industry
• Strong experience in Supplier Quality Management (supplier audits, qualification, performance monitoring)
• Hands-on experience with Manufacturing Quality support in a regulated environment
• Experience with CAPA, Client, SCAR, Root Cause Analysis (RCA)
• Knowledge of FDA 21 CFR Part 820 and ISO 13485
• Experience with risk management (ISO 14971)
• Familiarity with process validation (IQ/OQ/PQ) and statistical tools