Quality System Engineer

Summary: Responsible for reviewing, evaluating, updating, and creating Quality Management System (QMS) process documents.
Additional responsibilities include utilization of the Process Approach, making connections within the Global QMS documents, Process Mapping, SIPOC analysis, and facilitating global reviews for completed draft documents.
Responsibilities: ·     Researching, writing, and producing quality system process documents utilizing existing document content.
This includes the creation of Process Maps, SIPOCs, RACIs, and a standardized writing technique.
·     Editing and ensuring the quality of technical documents ·     Facilitating global reviews for completed draft documents, troubleshooting issues, and managing other aspects of the development of the new documents.
·     Identifying and documenting process risks, records generated, and process indicators/measures.
·      Collaborating with internal teams on product and document requirements.
·      Identification of potential Quality System compliance gaps based on common global quality system standards and regulations.
Qualifications: ·      Bachelor's Degree in Life Science, Engineering, or related discipline.
·      Minimum of 2 years' experience focused on quality System architecture, development, implementation, and continuous improvement.
Including direct experience creating and issuing quality system process documents.
·      Expert level proficiency with Microsoft Word, Excel, Visio, and Office.
·      Excellent English written communication skills.
·      Working knowledge of common Global Quality System standards Location: Full Remote working  Candidates (D.lgs n. 198/2006) are invited to read the privacy policy pursuant to articles 13 e 14 about Reg.
EU 679/2016 at the following address: https://www.enginium.eu/entra-nel-team/privacy-candidati/