Sr. QT Customer Service Program Manager

Siemens Healthineers

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Varian Medical Systems, a Siemens Healthineers company is seeking a Sr QT Customer Service Program Manager to support from our site in Atlanta, Georgia. In this role you will provide support to the Varian Radiation Oncology Solutions (ROS) Customer Service Organization (Customer Support Services / Sales & Marketing Operations) subsidiaries to achieve and/or maintain ISO13485 and other local country specific certifications.

Requirements

Basic education in engineering, natural science, or equivalent.
5 years minimum experience in QA, preferably in the Medical Device Industry. With knowledge and understanding of FDA Quality System Requirements (QSR), ISO13485:2016 certification requirements and EU regulations.
Experience working in a multi-national / language environment
Ability to communicate and work with multi-functional teams and diverse cultures
Excellent organization skills, high quality output and good interpersonal and communication skills.
Fluent in English, written and verbal.
Willing to travel 20 – 30%
Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.

Nice To Haves

Advanced degree preferred.
Ideally good German skills (other languages welcome).
Experience with SAP or equivalent ERP product and productivity software desired.

Responsibilities

Cooperate closely with Local, Regional and Global business and QA/RA functions.
Act as local face of the QA/RA organization for EMEA
Perform internal and support external audits; oversee and support the effective implementation of corrective and preventive actions.
Provide Training to the different operations sites
Approve and maintain Customer Service Suppliers
Support the CAPA / IR system as QT Reviewer to ensure timeliness and proper documentation
Create and maintain a QA/RA expertise with the goal to ensure that the ROS CS organization (Customer Support Services / Sales & Marketing Operations) in EMEA adhere to the global Varian Medical Systems (VMS) Corporate Quality Manual (QM) and Quality System Documentation (QSD).
Ensure continuous process and service quality improvements based on collected quality measures.
Support and consult the operations in their efforts to meet the required quality.
Perform as an independent QT reviewer for the Customer Facing Organization internal and external Quality Audits, initiate CAPAs, and assure that the CAPA Process is followed.
Support the operations in fulfilling Regulatory Requirements to maintain ISO 13485 compliance.
Ensure adherence to the relevant processes.
Collaborate with QA and business managers to implement and Maintain the global Quality System for the CS Organization:
Manage relevant elements of the Quality Manual (Sales, Marketing, Installations, Service and Complaint Handling) in close cooperation with the business managers.
Manage process documentation (procedures, work instructions, forms) and records
Provide Training to the operation
Maintain and improve purchasing controls (supplier management) for suppliers in the Customer Facing Organization.
Support market feedback processes (helpdesk, complaint handling) and field safety actions.
Communicate effectiveness of Quality System, quality and regulatory requirements, objectives and accomplishment.
Investigate significant quality and process problems and develop solutions.