Quality Engineer, Operations Support at Cook Inc. in Bloomington, Indiana

Job Description:

Quality Engineer, Operations Support

Posting Date 19 hours ago (10/28/2020 11:03 PM)

Requisition ID 2020-8071 Job Location(s) Bloomington IN United States Shift Type First Position Type Full Time Company Cook Inc. Category Quality

Overview

The Operational Support Quality Engineer at Cook Inc. serves as the lead quality representative of operational support subsystems: environmental monitoring, facilities, calibration, quality testing laboratories, information technology, and data control. The Quality Engineer fulfills the role of both contributor and independent reviewer of key operational outputs.

Responsibilities

- Provide quality support for environmental monitoring, including impact assessment of environmental excursions and appropriateness of resuming production after an excursion
- Facilitate development and implementation of environmental controls (qualification, sampling plans, trending, etc)
- Assist with planning facility expansions and modifications
- Review Software Qualifications as needed
- Perform investigation of product nonconformances and 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 quality-related issues
- Perform work per external and internal quality standards
- Interface with internal and external groups on quality-related 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, operations, 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
- Plan, review, and approve change requests

Qualifications

- Bachelors degree in Engineering
- Masters degree preferred
- Demonstrates knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971) preferred
- Professional certification (e.g. ASQ, Six Sigma, etc.) preferred
- Proficiency in statistical, quality, and continuous improvement methods and tools preferred
- Proficiency in Microsoft Office software (Word, Excel, PowerPoint, and Outlook) is required
- Strong organizational skills required
- Critical thinking and attention to detail required
- Excellent verbal communication skills and technical writing required

Physical Requirements: