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 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.- 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.