Cook Inc. is seeking a Quality Engineer to act as the lead quality representative for specific product lines, ensuring quality standards are met throughout the product lifecycle from development to post-market surveillance.
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.
Responsibilities
- Facilitate development and implementation of production controls (e.g. qualification, process capability, sampling plans, validation, etc.)
- Perform investigation of product nonconformance/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
- Conduct Risk-based decision making and effective resolution of issues
- Lead or support CAPAs as necessary
- Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.
Other
- 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
- May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.)
- Provide leadership in the understanding of medical device regulations and best practices
- Manage conflict resolution as it relates to technical situations
- Must work and interact effectively and professionally with and for others throughout various levels of the organization
- Must strictly adhere to safety requirements
- Bachelors degree Biomedical Engineering, Mechanical Engineering, Industrial Engineering,
- 3-5 years of experience
- Professional certification (e.g. ASQ, Six Sigma, etc.) preferred
- Strong organizational skills
- Critical thinking and attention to detail required
- Excellent verbal communication skills and technical writing
- Works under general office environmental conditions, including time in manufacturing environment and biohazard lab
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
- Occasional travel may be required
