Getinge · 6 days ago
Senior Quality Systems Engineer (Remote, US)
United States
Full-time
Remote
Mid, Senior Level
$112K/yr - $120K/yr
5+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. The Senior Quality Systems Engineer will provide expertise to enhance the Quality Management System and ensure compliance with applicable regulations, while leading various quality forums and collaborating with stakeholders.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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.)
Qualification
Required
A Bachelor's degree in engineering, Science, or other related field is required
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 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
Preferred
ASQ, RAC, Six sigma or other applicable certifications are a plus
Benefits
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
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
Recent News
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2025-12-19
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