Job Description

External

• 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\xe2\x80\x99 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 \xe2\x80\x9dGo-getter\xe2\x80\x9d
  • 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.
  • 4 - 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.