The Quality Engineer serves as the lead quality representative of certain product lines within manufacturing, ensuring adherence to quality standards and regulations.
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.
- Critical thinking and attention to detail required.
- Excellent verbal communication skills and technical writing.
Responsibilities
- 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.
- Conduct Risk-based decision making and effective resolution of issues.
- Lead or support CAPAs as necessary.
Other
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments withminimal supervision.
