As a Quality Engineer, you will play a critical role in ensuring the quality, reliability, and compliance of Egg Medical’s products. This position focuses on handling product returns, complaint management, field servicing, and customer support, in addition to core quality engineering responsibilities.

Key Responsibilities:

• Product Returns & Complaint Management: Oversee the process for product returns, including investigation, root cause analysis, and resolution of customer complaints. Ensure timely and accurate documentation and reporting in compliance with regulatory requirements.
• Field Servicing & Customer Support: Coordinate field service activities, including troubleshooting, repairs, and preventive maintenance.
• Quality Engineering: Develop, implement, and maintain quality control systems and processes to ensure product compliance with FDA, ISO 13485, and other relevant regulations. Perform risk assessments, validation, and verification activities for medical devices.
• Non-Conformance & Corrective Actions: Lead investigations into non-conformances and implement corrective and preventive actions (CAPA) to address quality issues and prevent recurrence.
• Documentation & Compliance: Maintain accurate records for quality processes, including complaints, returns, and servicing activities. Support internal and external audits to ensure adherence to regulatory standards.
• Continuous Improvement: Identify opportunities to enhance product quality, streamline processes, and improve customer experience. Collaborate with cross-functional teams to drive quality initiatives.

Qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Engineering, or a related field.
• 3+ years of experience as a Quality Engineer in a regulated industry, preferably medical devices.
• Experience in handling product returns, complaint management, and customer support.
• Familiarity with field servicing and technical support for medical devices is a plus.
• Experience with FDA regulations, ISO 13485, and other medical device quality standards.
• Proficiency in quality tools and methodologies (e.g., FMEA, SPC, CAPA).