What You Will Do

• Lead investigations of non-conformances and implement corrective and preventive actions to support timely issue resolution.
• Collaborate with Engineering, Production, and cross-functional teams to ensure products and processes meet quality requirements.
• Support internal and external audits by preparing documentation, participating in audit activities, and addressing audit observations.
• Escalate quality concerns to Quality Assurance and Engineering leadership and support resolution activities.
• Manage containment activities for non-conforming product, including identification, segregation, documentation, and reconciliation.
• Monitor, analyze, and trend quality data to identify risks, recurring issues, and improvement opportunities.
• Ensure compliance with the Quality Management System and applicable regulatory requirements.
• Apply statistical analysis and risk management tools, including Failure Mode and Effects Analysis (FMEA), to support decision-making and continuous improvement initiatives.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 3 years of experience in Quality Engineering.
• Working knowledge of 21 CFR Part 820, ISO 13485, and the Medical Device Single Audit Program (MDSAP).
• Advanced English proficiency, written and verbal.

Preferred Qualifications

• Experience supporting internal and external quality audits.
• Experience conducting investigations, risk assessments, and corrective and preventive action activities.
• Experience working in a regulated manufacturing environment.
• Experience using statistical analysis and quality risk management tools.