Design Engineer

3 weeks ago

Gurugram, India Stryker Global Technology Center Pvt Ltd. Full time
Work Flexibility: Hybrid

Who we want:

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business Data communicators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. Dedicated achievers. People who thrive in a fast-paced environment and are driven to complete projects that meet regulations and expectations. Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.

What you will do:

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 Change control Procedures and Processes. 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.

What you will need:

Total experience of 3-5 years with effectively working in QMS. Healthcare domain will be preferable Bachelor’s 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 Travel Percentage: 10%

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