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Gurugram, 122001, IN
Job details
Work flexibility: Hybrid
Req ID: R536305
Employee type: Full Time
Job category: Engineering
Travel:
Relocation: No
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Job description
Responsibilities and duties
- 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