Senior Quality Engineer

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.

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.

Travel Percentage: None