Knowledge of Change control Procedures and Processes.
Develop, establish, and maintain documentation quality systems as per ISO 13485 within the organization to ensure that all necessary systems and procedures are in place to satisfy customer requirements and audits.
Knowledge of QMS systems would be highly desired.
Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness
Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight
Implement and manage key performance indicators (KPIs) for change management domain
Ensure quality systems deliver cost effective results at all stages and across all relevant areas.
Communicating frequently across all project stakeholders to ensure project team and senior management are aware of upcoming milestones and risks/issues.
Support in the preparation, participate and follow up to Internal/external audits
Demonstrated experience processing ECNs, CAs and procedural documentation through electronic document management systems.
Good experience of working with multiple teams and collaborating across geographically spread multi-functional teams
Understanding of medical device regulations applicable to devices, particularly standards
Experience/skills required
Total experience of 1-5 years with effectively working in QMS. Healthcare domain will be preferable
Educational qualification - Bachelors in Mechanical Engineering/Bio-Medical Engineering
Knowledge of Windchill/One PLM or a similar system will be an added advantage.
Good analytical and problem-solving skills.
Understanding of NC, CAPA & QMS terminologies
Excellent communication skills.
Influencing /leading without authority with Cross functional Team
