The Post Market Quality Engineer at Cook Inc. serves as the lead post market quality representative of certain product lines and is responsible for conducting complaint investigations, post market surveillance, and supporting field actions as it relates to those product lines. The Post Market QE must perform work per external and internal quality standards.
• Interface with internal and external groups on post market quality-related issues
• Conduct complaint investigations as needed per ISO 13485 and 21 CFR 820.198 ("Complaint Files")
• Complete complaint investigations in a timely manner
• Assess product risk per quality system requirements and initiate/revise documentation as necessary including, but not limited to, Quality Engineering Risk Assessments (QERA),Design/Process Failure Modes Effects Analyses, and Health Risk Assessments.
• Perform root cause analysis as necessary for timely completion of complaint investigation
• May interface with internal or 3rd party audits (FDA, Notified Body, etc.)
• Gather data and support post market surveillance activities and action activities per quality system requirements and as necessary
• Assign work and monitor complaint investigator activities as necessary
• Provide leadership in the understanding of medical device regulations and best practices as it relates to post market quality activities.
• Work closely with Regulatory Reporting to ensure accurate and timely reporting of adverse events to regulatory bodies
• Bachelor's degree in a scientific discipline or equivalent experience
• Knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971) preferred
• Professional certification (e.g. ASQ, Six Sigma, etc.) preferred
• Proficiency in statistical, quality and continuous improvement methods and tools
• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required
• Works under general office environmental conditions, including time in manufacturing environment and biohazard lab