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Operations Quality Engineer

Gurugram, HR
Job Code:
  • Manufacturing & Production
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Job Details

Roles and Responsibilities Ensure high level of compliance to FDA QSR/cGMPs and ISO standards in all assigned areas. Participate in continuous process improvement activities as related to the direct part marking process. Participate with project teams with internal departments to support product and/or process design and development activities. Review inspection plans and operation sheets as related to product drawing changes. Assist in development and execution of process and equipment validation/qualifications (IQ, OQ, PQ). Submit product and/or process change control documentation and specifications. Manage the first article inspection deliverables for all the DPM parts. Demonstrate results orientation, ability to multi-task, learn quickly, prioritize and accomplish work with limited supervision. Direct responsibility to escalate issues to management that can impact project performance. Responsible for the timely and quality deliveries of the assigned tasks Work as point of contact for all project related aspects with the stakeholders Ensure continual improvement in customer satisfaction, delivering higher value services and productivity Managing partnerships with vendors and other SMEs as needed Manage knowledge at various spectrums appropriately to avoid losing it and help newcomers pick it up fast Develop an open culture to instill confidence, diversity of perspectives and knowledge sharing. Demonstrated ability to exhibit a positive, energetic approach to teamwork, with a high degree of emphasis on accountability. Demonstrated ability to advocate product excellence and quality. Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines. Develop an environment to focus on customer needs Communicating frequently across all project stakeholders to ensure project team and senior management are aware of upcoming milestones and risks/issues. SUPERVISORY RESPONSIBILITY N/A. Technical Skill Set Understanding of regulations applicable to devices, particularly standards Knowledge of material selection, International standards, and norms Good experience in Risk Tables, DFM, Basic GD&T Knowledge of manufacturing process Knowledge of ECN Process Basic inspection techniques. Basic knowledge of marking processes like Laser marking, Engraving, etc. Knowledge of Design and Risk Management documents. Knowledge of QMS systems, ERP system would be highly desired (Windchill and Oracle preferred). Project Management Good experience of working with multiple teams and collaborating across geographically spread multi-functional teams Applied knowledge of project Management tools e.g. Microsoft Project, SharePoint, etc. Additional Excellent analytical skills. Effective interpersonal communications skills. Blueprint/Engineering schematic reading and interpretation. Basic PC skills. US FDA quality regulations 21CFR part 820 ISO 13485 standards NC/CAPA process Trackwise and windchill knowledge
Degree: ME/ M.Tech./ MS (Engg/ Sciences)

Additional Degree: BE/ B.Tech (Engineering)

Experience: 2-4


Quality Assurance | Quality Control | Quality Inspection
Applying for this job will take you to an external site


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