Senior Quality Systems Engineer (US, Remote)
About The Position
The Senior Quality Systems Engineer independently provides hands-on subject matter expertise to support the maintenance and continuous improvement of Getinge’s Quality Management System (GetQMS). The role leads ongoing management and enhancement of the GetKPI process and GetQMS platform to support consistent execution of global quality processes and inspection readiness. It coordinates changes related to platform and process enhancements and partners with IT, Quality process caretakers, and other subject matter experts to improve reporting, automation, and QMS processes. The position also supports continuous improvement initiatives, including simplifying processes, improving reporting, and introducing appropriate automation. The position is fully remote, with a preference for candidates in the Eastern Time Zone.
Requirements
- Bachelor’s degree in Engineering, Quality, Life Sciences, Information Systems, or a related field.
- At least 5 years of experience working within a regulated Quality Management System, preferably in the medical device or life sciences industry.
- Working knowledge of quality metrics, KPI governance, trending, and performance monitoring.
- Experience with SharePoint from a business ownership, content management, or governance perspective.
- Experience partnering with IT or technical teams to implement system, reporting, or workflow enhancements.
- Experience supporting system or process changes through requirements definition, testing, implementation, and change control.
Nice To Haves
- ASQ, Six Sigma, or other applicable certifications.
- Familiarity with data visualization tools such as Power BI.
Responsibilities
- Serve as business process owner for GetKPI, ensuring effective operation and continuous improvement of the global KPI process.
- Facilitate implementation of approved changes across GetKPI procedures, the GetKPI Web Application, Power BI, and associated reporting.
- Partner with Quality Process Caretakers and other stakeholders to support consistent interpretation and application of KPI requirements.
- Lead business requirements, change controls, testing, implementation, and communication activities for GetKPI enhancements.
- Support GetKPI lifecycle activities, including creating new KPIs, changing thresholds and methodologies, updating scope, and retiring KPIs.
- Extract, organize, and analyze GetKPI data for Quality forums, management reviews, and other business needs.
- Develop and maintain GetKPI training materials and support training delivery.
- Serve as the Quality business owner for the GetQMS SharePoint platform, overseeing content organization, maintenance, and continuous improvement.
- Manage and enhance GetQMS capabilities, including the GetQMS News page, QMS content, and dashboards.
- Partner with IT and stakeholders to maintain site structure, navigation, content organization, and user access.
- Collaborate with IT to scope, test, and implement platform enhancements and new functionality.
- Identify opportunities to improve how QMS information is communicated, accessed, and used across the organization.
- Develop and maintain GetQMS platform training materials and support training delivery.
- Support authoring, revision, and ongoing maintenance of QMS documents to keep content current, effective, and aligned with GetQMS requirements.
Benefits
- Health, dental, and vision insurance benefits
- 401(k) plan with company match
- Paid Time Off
- Wellness initiative and Health Assistance Resources
- Life insurance
- Short- and long-term disability benefits
- Health and dependent care flexible spending accounts
- Commuter benefits
- Parental and caregiver leave
- Tuition reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Senior
