The business problem that Cook Incorporated is looking to solve is to ensure the quality of their medical device products by having a lead quality representative who can oversee product development, manufacturing, post-market surveillance, and/or CAPA.
Requirements
- Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
- 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
- Professional certification (e.g. ASQ, Six Sigma, etc.) preferred
Responsibilities
- Perform work per external and internal quality standards
- Interface with internal and external groups on quality-related issues
- Support product development and transfer to manufacturing
- Facilitate development and implementation of production controls. (e.g. qualification, process capability, sampling plans, validation, etc.)
- Perform investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues
- Plan, review, and approve change requests
- Execute risk assessment as needed and facilitate development and completion of risk file documentation
Other
- Bachelor's degree in Engineering or a Technical Life Science degree
- Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
- Strong organizational skills
- Critical thinking and attention to detail required
- Excellent verbal communication skills and technical writing
