Quality Engineer

Merck•Milwaukee, WI

8d•Onsite

About The Position

The Quality Engineer at the Milwaukee, WI site assists with the development, implementation, monitoring, and continuous improvement of Quality Management System (QMS) to ensure compliance with internal policies/procedures, ISO 9001, Good Distribution Practices, cGMP and customer requirements.

Requirements

Bachelor's degree in Chemistry, Biology or other Life Science disciplines OR Chemical Engineering, Industrial Engineering or other Engineering disciplines OR Operations Management, Supply Chain Management or other Business disciplines
5 + years of experience in Quality OR in manufacturing, chemical production, analytical laboratory and/or distribution.

Nice To Haves

Knowledge of Quality Systems and strong Root Cause Analysis/CAPA skillsets.
Ability to develop objectives and independently develop actions to meet those objectives.
Possesses excellent organizational, written, and verbal communication skills, with a proven ability to collaborate effectively both within and across departments.
General understanding of (current) Good Manufacturing Practices and ISO Quality Systems
Competent knowledge of and ability to use Microsoft Word, Excel, Access, SAP and eDMS systems.
Detail-oriented professional capable of managing multiple projects simultaneously, delivering clear and logical presentations, and effectively solving problems using data analysis and statistical methods.
Understanding of the processes in the DC (product flow, Manhattan, and SAP)
Capacity to independently make decisions to drive work forward

Responsibilities

Monitors receiving, production, packaging, and distribution processes for standard compliance while developing monitoring criteria and remediation activities throughout the manufacturing lifecycle.
Leads and assists with quality projects to ensure site compliance with customer and Life Science requirements, serving as the Quality representative for process, equipment, and facility validation, qualification, and verification activities.
Provide Operations support on the implementation, monitoring, and advancement of the QMS.
Serve as a Quality representative for the site.
Participate in monitoring, and advancement of the following QMS focal points: Change Management, CAPA, Deviation Management, Training Management, Documentation Management, Complaints, Field Corrective Actions, and Returned Materials (RMA), Supplier Quality Management, Audit Management, Quality Risk Management
Quality Engineers may be assigned to specific QMS areas as their primary, day-to-day focus.
Quality Engineers are expected to independently lead in their areas of expertise and to provide guidance to their peers and less senior team members.