Lead Engineer - Quality Management

Job Description

Quality Culture:
 Plan and implement LIVE Quality culture within project and organization level (Implement the defined processes, optimize existing processes, initiate process improvements, and drive continuous improvements (CI) in projects)
 Work with internal delivery team and other functions in order to meet the specified success criteria of project
 Ensuring compliance (of products) with legal and normative requirements through proactive risk management and mitigation strategies
 Collaborate with onsite teams to improve process efficiency
 Drive best practices within the organization
 Coach team on delivery excellence

  Process Improvement and Management:
 Drive process compliance in the projects (Active support in the complete lifecycle process of the medical device - starting with product definition till End of Support)
 Assist the Project Manager in implementing the quality system within the project based on the documented project quality plan
 Ensure that all project quality records are maintained through Preparation, performing and control of Main Reviews (R-Reviews) as project milestones and release of project phases as well as product release
 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 projects and in compliance with statutory requirements
 Participate in process definition by creating new processes and reviewing the processes
 Train and provide guidance to project teams on quality issues and translate the business partner’s (Syg QMS) requirements and expectations to project teams
 Perform metrics and defect prevention activities at both organization level and within projects
 Identify opportunities to improve productivity and efficiency with lower costs, reduce non-conformance costs
 Initiate and moderate the root cause analysis and monitor effective implementation of CAPA

  Reporting and Coordination:
 Prepare and provide input to the periodic reports
 Interface with SEPG to provide requisite in process data / analysis

  Audits and Assessments:
 Conduct / Participate in Process Audit, Internal Audit and External Audits
 Coordinate and ensure closure of audit findings in within the projects

 Qualification Requirements
 Bachelors or Masters in Engineering / MCA having an excellent academic track record.
 Prefearable experience in Healthcare Domain
 6 to 8 years of overall experience in Quality Assurance with atleast 2 years of experience in multisite projects
 Proficiency in working in a distributed product development environment
 LEAN (especially value stream mapping), KAN-BAN implementation experience
 2+ years of Work experience in various AGILE Methodologies
 Work Experience in various CI / CD environments and Lifecycle tool automation
 CMMi framework and its implementation in the organization
 Knowledge of Quality standards like ISO 9001:2008, ISO13485, CMMI
 Knowledge of Product related standards (e.g. ISO 62304, IEC 62366)
 Knowledge of legal and standards requirements for medical device (e.g. 21CFR820 QSR FDA, MDD/MPG, Canada MDR, Japan PAL, Brazil Resolution 59, Taiwan PAL)
 Usage of quality tools for analysisMetrics data analysis and decision making
 Experience in Quality Management in Projects.
 Skilled in Statistical Process Control, Quantitative Project Management, MS Excel scripting

 Highly energetic and ”Go-getter”
Executed Process Improvement Projects across multiple locations
 Full process management lifecycle experience
 Worked in cross functional teams (product management, development, QA, customers), understand team dynamics and priorities of each functional stakeholder and work with them to progress the project in a timely fashion
 Aptitude to appreciate business priorities so as to understand and appreciate dependencies in a distributed product development environment and resolve the dependencies

Job ID: 179874

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Job Type: Full-time

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