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