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)
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.
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.
