Quality Engineer

Overview

The Quality Engineer is a vital member of our quality team, responsible for ensuring the integrity and compliance of our medical devices throughout the product lifecycle. This role involves leading quality assurance activities, supporting continuous improvement initiatives, and collaborating across functions to uphold Cook Medical’s high standards of quality and regulatory compliance.

• Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, and other applicable standards.
• Act as the primary contact for quality issues, interfacing with internal teams and external stakeholders.
• Conduct risk assessments and develop risk management documentation, including FMEAs.
• Lead investigations into product non-conformances and complaints, performing root cause analysis and implementing CAPAs.
• Review and approve change requests, ensuring compliance with quality standards.
• Collaborate with cross-functional teams to drive quality improvements and product enhancements.
• Support internal and external audits, providing documentation and ensuring audit readiness.
• Analyze quality data to identify trends and opportunities for process improvements.
• Support product lifecycle activities from design to post-market surveillance, addressing product-related risks.
• Provide guidance and mentorship to entry-level technical staff.
• Interface with regulatory bodies and third-party auditors, such as FDA and Notified Bodies.
• Manage conflict resolution related to technical quality issues.
• Maintain all required training and seek continuous professional development.
• Ensure compliance with safety policies and maintain a safe work environment.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 2-3 years of experience in quality engineering within a regulated industry, preferably medical devices.
• Proficiency in statistical analysis, quality tools, and methodologies (e.g., Six Sigma, FMEA).
• Strong understanding of medical device regulations (ISO 13485, 21 CFR 820, ISO 14971).
• Excellent communication skills, both verbal and written.
• Strong organizational skills with attention to detail and critical thinking.
• Project management experience and ability to work independently.
• Professional certification (e.g., ASQ, Six Sigma) preferred.
• Proficiency in Microsoft Office Suite.

• Office-based with some travel required.
• Ability to work at a computer for extended periods.
• Must adhere to safety and regulatory requirements.

• Ability to work collaboratively across teams and levels of the organization.
• Commitment to maintaining confidentiality and compliance with company policies.