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Siemens Healthcare

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4.3

based on 290 Reviews

Video summary

38 Siemens Healthcare Jobs

Lead Engineer- Quality Management

Siemens Healthcare

4.3

based on 290 Reviews

12-16 years

Bangalore / Bengaluru

1 vacancy

Lead Engineer- Quality Management

Siemens Healthcare

posted 1d ago

Job Role Insights

Flexible timing

Key skills for the job

Data Analysis Consulting Legal Advisory Auditing Risk Management QMS

+ 1 more

Job Description

xternal 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 standards and regulations like ISO13485, ISO 14971 and 21CFR820 QSR (knows in detail and practical application in regards to the Quality Management System)

- 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 organizations 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.

- 12 to 16 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.

Employment Type: Full Time, Permanent

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