Job Description

Overview

The Quality Engineer serves as the quality mentor and/or reviewer for all CAPA and RIC activities.

Responsibilities

• Perform work per external and internal quality standards• Interface with internal and external groups on quality-related issues• Conduct Risk-based decision making and effective resolution of issues• May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.)• Plan, review, and approve change requests• Perform quality assessment of root cause analysis of product or process CAPAs• Mentor CAPA owners in the use of root cause investigation tools and appropriate implementation activities• 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

Qualifications

• Engineer degree or a Technical Life Science degree• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) 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

Physical Requirements:

• 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