Senior Quality Systems Engineer (Remote, US)

Getinge•Wayne, NJ

32d•Remote

About The Position

The Senior Quality Systems Engineer independently provides hands-on subject matter expertise to support continuous improvement of the Getinge Quality Management System (GetQMS). This role leads creation, enhancement, and maintenance of various QMS documents. Additionally, the role facilitates Quality forums such as, Document Control Community of Practice, Change Review Board, etc. to drive alignment across QMS. This position also collaborates closely with IT and other stakeholders to maintain and improve electronic Document Management System (eDMS) performance, and provides support to document control operations. The position ensures sustained compliance with applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and ISO 9001, while maintaining key quality system infrastructure and records. This position is fully remote and requires travel of up to 25% and may include international travel.

Requirements

A Bachelor's degree in engineering, Science, or other related field is required. ASQ, RAC, Six sigma or other applicable certifications are a plus.
A minimum of 5 years' experience in Medical Device Quality Assurance, Quality Systems, Quality Engineering, or related functions.
Prior experience in independently applying Medical Device regulations and standards such as, 21 CFR 820, ISO 13485, EU MDR, etc.)
Hands-on experience with electronic Document Management Systems (e.g., M-Files, MasterControl, Veeva, TrackWise DOC, Documentum, etc.).
Must have organizational skills and attention to detail.
Must demonstrate the ability to solve problems.Must possess good communication skills and be able to communicate to all levels of organization.
Must have ability to identify technical user issues and troubleshoot basic systems issues.
Must demonstrate ability to work independently and manage multiple tasks and priorities.
Must demonstrate sound judgment and strong decision-making skills.
Must show initiative for process improvment and ability to work cross functionally to resolve issues.
Must demonstrate effective influencing and change management skills.
Proficient in using Microsoft Office Products such as Word, Excel, PowerPoint, SharePoint, etc.

Responsibilities

Creates, revises, and maintains Quality Management System (QMS) documents in accordance with internal procedures and applicable regulatory and standard requirements.
Leads the Document Control Community of Practice, driving best practices, and continuous improvement of document control processes across the organization.
Facilitates the Change Review Board by coordinating change evaluations, impact assessment, and implementation strategy per established change control procedures.
Provides overall support and guidance to document users on using electronic Documentation Management System (eDMS), DCR process, etc.
Collaborates with IT on troubleshooting eDMS issues as well as identifying and implementing improvement opportunities.
Performs periodic reviews of open Quality Plans and provides status updates when needed.
Assists with creating and delivering training material.
Owns Nonconformances (NCs) and Corrective and Preventive Actions (CAPA) to address QMS deficiencies.
Supports internal audits, external audits, and regulatory inspections by preparing documentation, serving as a subject matter expert during audits, and supporting responses to audit observations and corrective actions.
Assists with other Management Controls related items (e.g., KPIs, Management Reviews, etc.).