Senior Quality Manufacturing Engineer

Overview

The Quality Engineer serves as the lead quality representative of certain product lines within manufacturing.

• 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.
• Conduct risk-based decision making and effective resolution of issues.
• Lead or support CAPAs as necessary.
• May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.).
• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.
• Provide leadership in the understanding of medical device regulations and best practices.
• Manage conflict resolution as it relates to technical situations.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• 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 with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

• Engineer degree and 5-8 years of experience.
• Demonstrates knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971).
• 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.
• Strong organizational skills.
• Critical thinking and attention to detail required.
• Excellent verbal communication skills and technical writing.