Quality Engineer

We are seeking an experienced Quality Engineer with a strong background in the medical device industry to support quality and manufacturing operations. The ideal candidate will have hands‑on experience with quality systems, process improvements, compliance activities, and cross‑functional collaboration within a regulated environment.

• Support quality assurance activities for medical device manufacturing and production processes
• Assist with CAPA, NCR, deviation investigations, and root cause analysis
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements
• Participate in risk management activities including FMEA and hazard analysis
• Review and maintain quality documentation, SOPs, and validation records
• Support process validation activities including IQ/OQ/PQ
• Collaborate with manufacturing, R&D, and supplier quality teams to resolve quality issues
• Conduct internal audits and support external regulatory inspections
• Analyze quality metrics and drive continuous improvement initiatives
• Assist with complaint investigations and non‑conformance trending

• Bachelor’s degree in Engineering or related technical field
• 3+ years of Quality Engineering experience in the medical device industry
• Strong knowledge of FDA regulations, ISO 13485, and quality systems
• Experience with CAPA, validations, audits, and risk management
• Familiarity with tools such as FMEA, SPC, Root Cause Analysis, and Lean methodologies
• Excellent communication and problem‑solving skills

• Experience working in a regulated manufacturing environment
• Knowledge of supplier quality and process improvement initiatives
• Ability to work independently and within cross‑functional teams