[Hiring] Senior Quality Systems Engineer @Getinge

Role Description

The Senior Quality Systems Engineer independently provides hands-on subject matter expertise to support the maintenance and continuous improvement of the Getinge Quality Management System (GetQMS). This role leads the ongoing management and enhancement of the GetKPI process and GetQMS platform to support consistent execution of global quality processes and inspection readiness.

The position coordinates change activities associated with platform and process enhancements. It also partners with IT, Quality process caretakers, and other subject matter experts to improve reporting, automation, and QMS processes. This role supports continuous improvement initiatives across GetQMS, including opportunities to simplify processes, improve reporting, and introduce appropriate automation.

The position is fully remote and the preferred candidate will be in the Eastern Time Zone.

Key Responsibilities

• GetKPI Business Process Ownership
  • Serve as the 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 associated with GetKPI enhancements.
  • Support GetKPI lifecycle activities, including new KPIs, threshold and methodology changes, scope updates, and retirement of KPIs.
  • Extract, organize, and analyze GetKPI data to support Quality forums, management reviews, and other business needs requiring KPI information.
  • Develop and maintain GetKPI training material and support delivery of training to promote consistent understanding and effective use of the GetKPI process and system.
• GetQMS Site Business Process Ownership
  • Serve as the Quality business owner for the GetQMS SharePoint platform, with responsibility for content organization, maintenance, and continuous improvement.
  • Manage and enhance GetQMS capabilities, including the GetQMS News page, QMS content, and dashboards.
  • Partner with IT and appropriate stakeholders to maintain effective 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 material and support delivery of training to promote consistent understanding and effective use of the platform.
  • Support the authoring, revision, and ongoing maintenance of QMS documents to ensure content remains current, effective, and aligned with GetQMS requirements.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Information Systems, or a related field. ASQ, Six sigma or other applicable certifications are a plus.
• A minimum of 5 years’ experience working within a regulated Quality Management System, preferably within 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.
• Familiarity with data visualization tools such as Power BI.
• Experience supporting system or process changes through requirements definition, testing, implementation, and change control.

Requirements

• The base salary for the position is a minimum of $97,000 and a maximum of $125,000 plus 10% Annual Bonus.

Benefits

• Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off.
• Wellness initiative & 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.