- Experienced manager from the medical device industry capable of managing and delivering new projects to manufacture;- Certificate compliance experience with a strong understanding of ISO 13485:2016- Qualified internal auditor;- Review Engineering Change Control; - Apply appropriate risk assessment tools (e.g. PFMEA, CPA) to carry out effective mitigation activities at key phases during the project and continual improvement process;- Managing Quality Documentation, addressing non-conformance reporting;- Calibration and Maintenance: specify lab equipment requirements and design the procedure to testing;- Work closely with management on process improvement, quality and technical supports;- Review CAD drawing and technical spec; Defining manufacturing requirements for process developments, incorporating information from various business sources;- Production process validation and analysis incl:Process control, GR&R, Capability, FMEA, and SPC as required;- Providing training to quality and production team with coordination of prototype build activities;- Six sigma and lean manufacturing;- Liaising with customers, stakeholders and suppliers.

Coordinate internal resources and third parties/vendors for the execution of multiple projects and brandings.Developing project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility.Develop detailed project plans to track progressUse appropriate verification techniques to manage changes in project scope, schedule and costsMeasure project performance using appropriate systems, tools and techniquesReport and escalate to management as neededManage the relationship with the client and all stakeholdersPerform risk management to minimize project risksEstablish and maintain relationships with third parties/vendorsCreate and maintain comprehensive project documentationAll quality management tasks

- Assisted the product development team in designing and testing implantable medical devices.- Conducted research on new materials and technologies to enhance product performance and efficiency.- Supported the development of manufacturing processes and performed troubleshooting to address production issues.- Collaborated with engineers to create 3D models and prototypes using CAD software.- Assisted in the execution of verification and validation protocols, documenting results and recommending design improvements.