Offers “Siemens”

Expires soon Siemens

Engineer - Quality Management

  • Internship
  • Bengaluru (Bangalore Urban)
  • Sales

Job description



External Job Description

·  Quality Culture:
·  Ensure awareness for quality focus to increase customer satisfaction, particularly in the development process
·  Plan, implement and live Quality culture within Product Line and organization level (Implement the defined processes, improve product quality, initiate process improvements, and drive continuous improvements (CI) in projects)
·  Ensuring compliance (of products) with legal and normative requirements (including tailoring of processes as appropriate)
·  Effectively review product risk management activities (including Risk Analysis, Risk Management Report)
·  Collaborate with onsite teams to keep project teams aligned with headquarters’ expectations
·  Drive best practices within the organization

 

·  Quality Management:
·  Define quality strategy in Quality Management Plan
·  Drive process compliance in the complete lifecycle process of the medical device - starting with product definition till End of Support
·  Act as independent reviewer for design reviews acc to QSR 820.30 (e) with the responsibility of defining and documenting the overall result of the design review.
·  Work with internal delivery team and other functions in order to meet the specified Quality Goals of the project
·  Supporting and consulting of employees in implementing and realizing the processes as well as decision about tailoring of defined processes - both according to the needs of the business and in compliance with statutory requirements
·  Identify opportunities to improve productivity and efficiency with lower costs, reduce non-conformance costs
·  Initiate and moderate the root cause analysis and monitor effective and timely implementation of CAPA

 

·  Reporting and Coordination:
·  Prepare and provide input to the periodic reports as needed by headquarter team

 

·  Audits and Assessments:
·  Conduct / Participate in Internal Audit and External Audits using MDSAP methodology.
·  Coordinate and ensure timely closure of audit findings

 

·  Qualification Requirements
·  Bachelors or Masters in Engineering / MCA having an excellent academic track record.
·  Proficient in managing Quality of complete Software Medical Device Development lifecycle in distributed international environment.
·  Experienced in latest trends of Software Product Development (e.g. Trunk Based Development, Continuous Delivery (DevOps)  etc)  
·  Advanced knowledge of quality tools for Metrics data analysis and decision making
·  Advanced computer skills (MS Office tools like Word, Access, Excel, PowerPoint and Outlook)
·  Highly energetic and ”Go-getter”
·  Proven ability to independently plan and successfully execute multiple projects based on business priorities.
·  Display of a high level of critical thinking in bringing successful resolution to high-impact, complex and cross-functional problems is expected. 
·  Advanced knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues.
·  Excellent organizational and communication skills (e.g. Moderation, presentation to all levels).
·  Auditor experience in Medical Device area is preferred.
·  6 - 8 years of successful experience in Quality Management and demonstration of Key Responsibilities and Knowledge as mentioned above. Advanced degree MAY be substituted for experience, where applicable.  

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Job Type: Full-time

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