Quality Engineer

The Quality Engineer position involves initiating quality assurance activities for medical devices in compliance with FDA regulations and international standards. The role supports device complaint investigation, develops inspection processes, and manages quality system metrics.

• Initiate medical device quality assurance activities in accordance with FDA Quality System Regulation and ISO13485.
• Support device complaint investigations and failure analysis.
• Develop and document incoming inspection processes.
• Provide in-process QA support, including inspection and document review.
• Manage the sterilization process, including validations and product sterile loads.
• Lead Material Review Board efforts for nonconforming material.
• Interface with suppliers and lead QA interactions with contractors.

• Knowledge of FDA Quality System Regulation and ISO13485 standards.
• Experience in quality assurance activities for medical devices.
• Strong analytical and problem-solving skills.
• Ability to manage corrective action and quality improvement activities.
• Familiarity with internal quality system auditing.
• Effective communication skills for supplier interactions.
• Ability to work in a team-oriented environment.