Job Description - Quality Professional
Leads Quality Management System and upkeep throughout the Siemens Healthcare Sales and Service organization by performing a range of QMS processes with respect to international standards and Siemens Healthineers global requirements.
Areas of Responsibility :
Ensuring compliance to international quality standards like ISO 9001 and ISO 13485 Active leading role in complying to the Quality process requirements from Siemens Healthineers global. Driving the organization and to ensure the compliance of service processes in line with global CS Quality requirements Lead and drive compliance to a range of specified Quality Management System processes, like document control system, Training management system, Quality Audit process (both internal and external),CAPA management, Complaint Handling, Management Review, etc., Prepares Quality related analyses, concepts, methods and tools, for management reporting. Advises business accountable management in specific Quality related issues. Ensures and Implements quality related standards, guidelines and programs in Siemens Healthcare Sales and Service organization. Supports Regulatory Affairs and EHS function for interface of activities with Quality. Keeps abreast of industry and legal trends in a specific quality area. Contributes to budget planning processes. Trains employees in a specific quality area. Ensures effective cooperation with both internal and external stakeholders; clarifies issues
Business Specifications :
Ensuring and complying with applicable global standards and Siemens Healthineers global requirements in entire sales and service organization Ensuring Regulatory compliance in the responsible area of job
Dimension of Function :
Ensuring of Quality Management System processes in the sales and service organization, keeping abreast of new developments in quality requirements within medical device industry, timely reporting of any relevant issues, taking timely measures/ remediation to ensure compliance, ensuring zero regulatory enforcement with respect to Quality systems.
Contacts (Internal/ External) :
Service Management, Customer Support/ Technical Support, Sales, Supply Chain Notified Bodies, National Standards Authorities, Industry associations
Education and Experience
Graduate or Postgraduate in Engineering or Masters degree in Science with 8 - 10 years of experience Experience in Medical Device Industry with at least 6 years in Quality function Hands on experience of Quality Management System in medical device industry is a requisite Certification in ‘Certified Quality Engineer’ or ‘Certified Quality Auditor’ is not mandatory but an added advantage
Sub Job Family:
General Quality Management
Organization: Siemens Healthineers Company: Siemens Healthcare Private Limited Experience Level: Mid-level Professional Job Type: Full-time
Siemens India is a technology powerhouse that has stood for engineering excellence, innovation, quality and reliability. The company focuses on the areas of electrification, automation and digitalization. It is one of the leading producers of energy-efficient, resource-saving technologies; combined cycle turbines for power generation; and power transmission solutions. Siemens is a pioneer in infrastructure solutions and automation and software solutions for industry. The company is also a leading supplier of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. At the end of September 2016, Siemens India had around 16,000 employees (Number of employees is 16,000 including all group companies of Siemens in India). Siemens Limited, in which Siemens AG holds 75% of the capital, is the flagship listed company of Siemens AG in India.
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