Quality Engineer, Post Market

Posting Date 1 month ago(5/10/2021 3:08 PM)
Requisition ID
2021-8968
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Inc.
Category
Quality

Overview

The Quality Engineer serves as the lead quality representative of certain product lines within post-market surveillance and complaint investigation activities.

Responsibilities

- Perform work per external and internal quality standards.
- Interface with internal and external groups on quality-related issues.
- Perform investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.
- Execute risk assessment as needed and facilitate development and completion of risk file documentation.
- Conduct Risk-based decision making and effective resolution of issues.
- 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.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- 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.
- Execute investigations and investigation reviews involving used medical devices and handling of potentially bio-hazardous products.

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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