Quality Reporting Analyst (Center Valley, Pa)

The role of a Quality Analyst is overseeing and maintaining the quality and compliance of service delivery service records, with a strong emphasis on adherence to GDP, quality documentation, system workflows, and relevant compliance policies. It involves reporting, analyzing, and evaluating service records for quality and compliance.  

This position is responsible for 1) Defining processes and systems to meet quality goals, using KPIs for monitoring, 2) Managing programs and training records, 3) Ensuring compliance with FDA regulations and Medical Device Single Audit Program (MDSAP), 4) Identifying and solving process/system issues, 5) Utilize systems like Salesforce.com, SAP CRM, SAP ECC, and EtQ Reliance. 6) Ensuring field service and the Technical Assistance Center (call center) compliance and addressing service record problems. Responsibilities include recognizing opportunities to enhance process and/or system monitoring, identifying issues, and proposing potential solutions. The audit programs will function as key performance indicators (KPIs) or management by objectives (MBOs) for evaluating individual performance. The Quality Analyst plays a significant role in ensuring the organization's service delivery records and processes operate with efficiency, effectiveness, and compliance with quality and regulatory standards. Additionally, this role entails ensuring that Service Delivery complies with required quality standards, such as the FDA Quality System Regulation and ISO 13485. 

In this role, you will report to the Senior Manager of Technical Engineering and Quality, and will work closely with Quality Assurance/Regulatory Affairs and Service Delivery; Continuous Improvement, Quality, Technical Engineering, Field Service, Technical Assistance Center, Field Support, and IT. 

• Manage the Service Record Audit Program by auditing all types of service records such as Product complaints and non-complaints submitted by multiple field employee types and the Technical Assistance Center (phone support). This includes GDP (Good Documentation Practices), accuracy of quality failure codes for medical devices (Risk Summary Failure Codes), and reporting instructions.
• Manage and inspect statistically significant sampling of non-complaints service records for accuracy.
• Audit to Service Delivery processes and policies as it pertains to the Quality Management System (QMS).
• Serve as a Subject Matter Expert (SME) and point of contact for all Field Service, Technical Assistance Center, Field Support and their management for quality requirements, business compliance, and policy regarding service records.
• Report, troubleshoot, monitor, and manage the open transactions (complaints, non-complaints, and work orders) in Salesforce to ensure timely closure. This includes investigation and updating in Salesforce, SAP-CRM, and EtQ Reliance.
• Manage reporting and create dashboards to support performance accuracy and identify trends. Recommend and assist in creating materials for presentations, communications, and
• meetings/training as well as delivering training.
• Monitor the timeliness and completeness of training reports in SuccessFactors Learning Management System to ensure education and compliance. 
• All duties as assigned.

Required:

• Bachelor’s degree in business or equivalent knowledge required
• Minimum of 2 years’ experience working in a regulated environment such as FDA, ISO 13485, and/or medical device company required. 
• Skilled in creating Excel spreadsheets with charts, graphs, pivot tables, and VLOOKUPs, as well as developing dashboards.
• Experienced in working with software systems and preferably have knowledge of SAP-CRM, SAP-ECC, EtQ Reliance, and/or Salesforce.com systems.
• Office is in Center Valley, PA – Corporate Headquarters for the Americas. Ability to commute to the office.
• Currently a hybrid model for working in the office and from home. Subject to change.

Preferred:

• Knowledge of FDA regulations, ISO 13485 and HIPAA for medical devices preferred.
• Quality auditing skills preferred.
• Adept in robust troubleshooting and analytic skills, coupled with an extraordinary attention to detail.
• Effective written and verbal communication skills, including process writing.
• Proficiency in Microsoft Office, including Excel, Word, PowerPoint, and Visio is required. Familiarity with Smartsheet is a plus.