Quality Professional

Job description

Job Description

Job Description - Quality Professional

Position Headline

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

Job Family:

 

Quality Management

 

Sub Job Family:

General Quality Management

 

Function Type:

Individual Contributor

 

Job Location:

Mumbai/ Bangalore

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Mid-level Professional

Job Type: Full-time