Design Engineer -Packaging
Stryker GmbH
Publication date:
20 September 2024Workload:
100%Contract type:
Permanent position- Place of work:Gurugram
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