Job Title: Senior Quality Engineer

Work Location: Houston , Texas

Summary:

Seeking a detail-oriented Senior Quality Engineer to enhance and maintain Quality Management System (QMS) processes, support product development, and drive quality culture improvements within a medical device environment. This role involves collaboration with cross-functional teams, ensuring regulatory compliance, and supporting continuous improvement initiatives.

Responsibilities:

• Streamline and maintain QMS processes, including nonconformance, CAPA, supplier management, audits, and training activities.
• Support product design control activities to ensure devices meet specifications and industry standards.
• Develop and update documentation such as DMR, DHF, and DHR throughout product design and production.
• Revise and maintain risk management documentation for products as needed.
• Ensure compliance with quality standards and regulatory requirements during all phases of product development and approval processes.
• Enhance supplier relationships and manage supplier quality to ensure control over purchased products and services.
• Prepare for and support internal and external audits to monitor compliance with policies and regulatory standards.
• Investigate nonconformances, conduct root cause analysis, and implement effective solutions to quality issues.

Qualifications:

• 4+ years of Quality Engineering experience in the medical device industry.
• Working knowledge of FDA 21 CFR 820, ISO 14971, ISO 13485, and other relevant medical device regulations and standards.
• Strong analytical, problem-solving, and organizational skills.
• Proficiency in Microsoft Office applications (Excel, Word, Outlook).
• Excellent communication and teamwork abilities.

Published Category: Quality & Validation