Senior Quality Systems Engineer; Remote

Job Overview

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 the Document Control Community of Practice and Change Review Board to drive alignment across QMS. The 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.

• 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.).

• 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, Master Control, Veeva, Track Wise 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 system 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 improvement 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.

The base salary for this position is a minimum of $112,000 and a maximum of $120,000 plus 10% annual bonus.

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, Vision and Travel insurance benefits
• Registered Pension Plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Hybrid Work Arrangements (where applicable)
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer. Getinge will, at all times, comply with all applicable human rights and other legislation when considering all qualified applicants for employment. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.