33 applicants

Company

Original Job Post

Siemens Healthineers · 2 days ago

Quality Analyst

Cary, NC

Full-time

Onsite

Mid Level

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Responsibilities

Being a team player within a support team and sharing knowledge and experience with other team members

Providing information and answering questions on product recall/software enhancement status to internal partners

Providing solutions to business problems, looking for opportunities for lean processing, automation, and innovation

UAT testing and validating data in new automation and for changes to automation

Participating in frequent, unannounced FDA Audits and internal audits

Supporting product recalls by contacting customers through multiple means of communication, ensuring 100% customer response, monitoring and maintaining effective documentation of recall receipt, and driving the addition of automation to the process

Managing entire Update Lifecycle Process including Update planning, due date assignment, material availability, and on-time completion

Working closely with Product Support Teams/Business Units and Data Management Teams to ensure install base accuracy and data integrity for Compliance Reporting

Proactively identifying areas of risk with non-compliance to industry regulations for patient safety recalls and non-mandatory updates

Managing project milestones to ensure on-time completion and identifying actions required to keep them on track

Providing status updates and escalations to various levels of management when compliance and on-time completion are at risk

Providing reports on progress and actions on a regular basis by researching, documenting, and presenting findings

Performing and managing internal audits to ensure process compliance and accuracy across the organization

Qualification

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SAPMicrosoft Power PlatformLean Six SigmaLess than 5% travel

Required

BS/BA in related discipline, where required, or equivalent combination of education and experience.

2 years of SAP experience is required

Preferred

Microsoft Power Platform experience preferred

Lean Six Sigma certification preferred

Less than 5% travel

Company

Siemens Healthineers

Glassdoor

4.1

Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.

Founded in 1847