Quality Engineer
Posted Updated
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.