Quality Engineer

Job description

Work Flexibility

Onsite

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.

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.

Travel Percentage

None