Sr. QT Customer Service Program Manager

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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.

What You will do:

• 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

Department Duties

• 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.

Personal Duties

• 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.

What You will have:

• Basic education in engineering, natural science, or equivalent. Advanced degree preferred.

• 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.
  Ideally good German skills (other languages welcome).

• Willing to travel 20 – 30%

• Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.

• Experience with SAP or equivalent ERP product and productivity software desired.

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Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to