Quality Assurance Engineer

We are looking for a Quality Engineer!

Yyou will play a crucial role in ensuring the quality and compliance of our medical devices. You will be responsible for managing Corrective and Preventive Actions (CAPA) and Non-Conformance (NC) processes to identify, investigate, and resolve quality issues. Your work will involve collaborating with cross-functional teams to implement effective solutions and maintain regulatory compliance.

Key Responsibilities:

• Conduct thorough investigations into quality issues, utilizing tools such as root cause analysis, failure mode and effects analysis (FMEA), and statistical analysis.
• Collaborate with project teams to lead NC/CAPA processes, identify root causes of non-conformances, and implement corrective actions to prevent recurrence.
• Drive a culture of continuous improvement within the Quality group.
• Work closely with other departments such as manufacturing, engineering, R&D, and quality assurance to implement NC/CAPA solutions in a timely manner.
• Ensure NC/CAPA processes comply with relevant regulatory requirements (e.g., FDA, ISO 13485).
• Maintain detailed records of NC/CAPA activities, including investigation reports, action plans, and verification of effectiveness.
• Analyze data to ensure the site meets necessary CAPA and NCEP metrics.
• Monitor CAPA implementation aging and identify opportunities for site improvement.
• Support other Quality System processes at the site, such as internal audits, external audits by Notified Bodies, quality management review, document control, etc., as assigned and where qualified.

Required Qualifications:

• Bachelor's degree in engineering, quality management, or a related field.
• 2-3 experience in quality assurance within the medical device industry.
• English fluency including writing and speaking.