Requisition ID 2020-7922 Job Location(s) Bloomington IN United States Travel Less than 10% Position Type Full Time Company Cook Inc. Category Quality
Overview
The Non conformance Quality Engineer serves as the quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.
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
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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.